Subthalamic Steering for Therapy Optimization in Parkinson's Disease

Parkinson Disease Clinical Trial

— SANTOP  

Official title:

Subthalamic Steering for Therapy Optimization in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03548506
• Other study ID #: SANTOP
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus [STN_O] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact [STN_D].

Description:

Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation [STN_D] compared with standard omnidirectional STN stimulation [STN_O]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P < 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms

Exclusion Criteria:

• Cognitive impairment (Mini Mental State Exam < 20)

• Suicidality, Psychosis

• Other severe pathological chronic condition that might confound treatment effects or interpretation of the data

• Pregnancy

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Omnidirectional Deep Brain Stimulation of STN
Deep Brain Stimulation
• Directional Deep Brain Stimulation of STN
Deep Brain Stimulation

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases)	Tuebingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Abbott

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Levin J, Krafczyk S, Valkovic P, Eggert T, Claassen J, Bötzel K. Objective measurement of muscle rigidity in Parkinsonian patients treated with subthalamic stimulation. Mov Disord. 2009 Jan 15;24(1):57-63. doi: 10.1002/mds.22291. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electroencephalography	Electroencephalography (EEG)	up to 6 months post-operatively
Other	Electromyography	Electromyography (EMG)	up to 6 months post-operatively
Primary	Muscle Rigidity	Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (1)	MDS-UPDRS I	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (2)	MDS-UPDRS II	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (3)	MDS-UPDRS III	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (4)	MDS-UPDRS IV	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (5)	Bradykinesia evaluation	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (6)	Tremor evaluation	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (7)	Deep brain stimulation impairment scale (DBS-IS): the scale consists of 22 questions and 6 subscales; subscales: 1. postural instability and gait difficulties (range 0-20), 2. cognitive impaiment (range 0-20), 3. speaking problems (range 0-12), 4. apathy (range 0-12), 5. impulsivity (range 0-12), and 6. difficulties related to DBS device (range 0-12); ? 1-6 DBS-IS total range: 0-88; ? 1-5 DBS-IS total range: 0-76; higher values represent worsening of symptoms	6 months post-operatively
Secondary	Clinical motor and non-motor symptoms (8)	Clinical global impression self	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (1)	Modulation range	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (2)	Spatial with a visual Odd-Ball test	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (3)	Verbal Working Memory with an auditory Odd-Ball test	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (4)	Power of Attention (Cognitive Drug Research Battery)	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (5)	Digit Vigilance Accuracy (Cognitive Drug Research Battery)	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (6)	Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB)	6 months post-operatively
Secondary	Neurocognitive and non-motor symptoms (7)	Montreal Cognitive Assessment (MoCA)	6 months post-operatively
Secondary	Neuropsychiatric symptoms (1)	Beck Depression Inventory (BDI)	6 months post-operatively
Secondary	Neuropsychiatric symptoms (2)	Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory	6 months post-operatively
Secondary	Freezing of gait (1)	Capsit-PD	6 months post-operatively
Secondary	Freezing of gait (2)	Freezing of Gait Assessment Course	6 months post-operatively
Secondary	Quality of life	Parkinson's Disease Questionaire (PDQ-39)	6 months post-operatively