Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Parkinson Disease Clinical Trial

— ADROIT  

Official title:

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071847
• Other study ID #: ABT-CIP-10300
• Status: Recruiting
• Start date: November 26, 2019
• Est. completion date: September 2030

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: Natalie Brill, PhD
• Phone: +15122864383
• Email: Natalie.Brill[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Description:

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.

Subjects will be followed for 5 years after the initial programming visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2030
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.

2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.

2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.

3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.

4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Essential Tremor
• Movement Disorders
• Parkinson Disease
• Primary Dystonia
• Secondary Dystonia
• Tremor

Intervention

Device:
• Deep Brain Stimulation (DBS)
Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital - City Campus	Parkville	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa
France	CHU Gabriel Montpied	Clermont Ferrand	Auvergne
France	CHU Hopital Pasteur	Nice	Provence-Alpes-Azur
France	Fondation Rothchild	Paris	ILE
France	CHU de St Etienne	Saint-Étienne	Auvergne
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	North Rhine-Westphalia
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz	Rhineland-Palatinate
Germany	Universitätsklinikum Münster	Münster	North Rhine-Westphalia
Germany	Universitäts Klinikum Tübingen	Tübingen	Baden-Wurttemberg
Italy	Az.Osp. Universitaria di Ferrara	Cona	Emilia-Romagna
Italy	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Milano	Lombardy
Italy	Policlinico Universitario A. Gemelli	Roma	Latium
Spain	Hospital Universitari Germans Trias I Pujol	Badalona	Catalonia
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Virgen de Rocio	Sevilla	Andalusia
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	Chang Gung Memorial Hospital	LinKou	Ntaiwan
United Kingdom	Southmead Hospita	Bristol	South West England
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Wdbtshr
United Kingdom	The Walton Centre	Liverpool	North West England
United Kingdom	King's College Hospital	London
United States	Albany Medical Center	Albany	New York
United States	Beth Israe Deaconess Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State Medical	Columbus	Ohio
United States	Center for Interventional Pain & Spine	Exton	Pennsylvania
United States	Wright State University & Premier Health	Fairborn	Ohio
United States	Texas Movement Disorder Specialist	Georgetown	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Colorado Neurodiagnostics	Littleton	Colorado
United States	Neurosurgery One	Littleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Hospital	Miami	Florida
United States	Thomas Jefferson Department or Neurosurgery	Philadelphia	Pennsylvania
United States	Allegheny General Hospital Department of Neurosurgery	Pittsburgh	Pennsylvania
United States	University of California at Davis	Sacramento	California
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Willis-Knighton Medical Center	Shreveport	Louisiana
United States	University of South Florida - Department of Neurology	Tampa	Florida
United States	University of Aizona Health Sciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Finland,  France,  Germany,  Italy,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to 6 months
Primary	Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to1 year
Primary	Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to 2 years
Primary	Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to 3 years
Primary	Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to 4 years
Primary	Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.	Baseline to 5 years
Primary	Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.; The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 6 months
Primary	Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 1 year
Primary	Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 2 years
Primary	Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 3 years
Primary	Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability. The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 4 years
Primary	Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.	The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.	Baseline to 5 years
Primary	Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 6 months
Primary	Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 1 year
Primary	Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 2 years
Primary	Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 3 years
Primary	Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 4 years
Primary	Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.	The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.	Baseline to 5 years
Primary	Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 6 months
Primary	Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 1 year
Primary	Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 2 years
Primary	Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 3 years
Primary	Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 4 years
Primary	Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.	Baseline to 5 years
Primary	Incidence of device- and procedure-related serious adverse events at 6 months	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 6 months
Primary	Incidence of device- and procedure-related serious adverse events at 1 year	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 1 year
Primary	Incidence of device- and procedure-related serious adverse events at 2 years	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 2 years
Primary	Incidence of device- and procedure-related serious adverse events at 3 years	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 3 years
Primary	Incidence of device- and procedure-related serious adverse events at 4 years	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 4 years
Primary	Incidence of device- and procedure-related serious adverse events at 5 years	Serious Adverse Events related to the device and procedure will be assessed.; If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).; a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.; v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At 5 years