LONG TERM EFFECTS OF SPINAL CORD STIMULATION

Parkinson Disease Clinical Trial

— SCS for FOG OL  

Official title:

LONG TERM EFFECTS OF SPINAL CORD STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE OPEN LABEL EXTENSION TO H-49023

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06272955
• Other study ID #: H-54417
• Status: Enrolling by invitation
• Start date: January 4, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD. The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD. 1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients. 2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Description:

Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits. FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG. Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features. Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM. The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to sign inform consent
• Underwent SCS implantation as part of participation in H-49023

Exclusion Criteria:

• Severe dementia Inability to participate in motor or cognitive assessments assessments

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Spinal Cord Stimulator (SCS)
Patients are already implanted with device from the H-49023 study. The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space. The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nora Vanegas

Country where clinical trial is conducted

United States, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence of Adverse Events as assessed by Adverse Event reporting.	12-months
Secondary	New Freezing of Gait Questionnaire (NFOG-Q) score	The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life. The task ratings and scales are calculated into a summed NFOG-Q score. The scale is scored from 0-28. A score of 0 means least severe. A score of 28 means the most severe.	12month follow up period
Secondary	Gait and Falls Questionnaire (GFQ)	The Gait and Falls Questionnaire (GFQ) is a clinician-administered tool that aims to assess the specific time when the person experiences freezing of Gait as well as how often they fall. The task ratings and scales are calculated into a summed GFQ score. The scale is scored from 0-64. A score of 0 means least severe. A score of 64 means the most severe.	12month follow up period
Secondary	MDS-UPDRS score	The Movement Disorder Society (MDS) published a revision of the unified Parkinson's disease rating scale, known as the MDS-UPDRS. The Part III: Motor Examination portion of the scale assesses the motor signs of PD and is completed by the examiner. The measure is scored between 0-76 with 0 have the most abnormal motor signs and 76 having normal motor signs.	12month follow up period
Secondary	Timed Up and Go test (TUG)	The Timed Up and Go test measures gait velocity. The Timed Up and Go test is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.	12month follow up period
Secondary	Timed 10-meter walk (T10MW)	The 10-meter walk measures gait velocity. The 10-meter walk is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.	12month follow up period
Secondary	Mini-Mental State Examination (MMSE)	This is a test of cognitive function used to screen and track cognitive changes over time. The MMSE is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.	12month follow up period
Secondary	Montreal Cognitive Assessment Scale (MoCA)	This is a test of cognitive function used to screen and track cognitive changes over time. The MoCA is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.	12month follow up period
Secondary	Beck Depression Inventory (BDI-2)	The Beck Depression Inventory (BDI-2) is a 21-item, self-report rating inventory that measures characteristic, attitudes, and symptoms of depression during the past 2 weeks. The score range is 0-63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	12month follow up period
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a 21 self-reported items questionnaire that assess the intensity of physical and cognitive anxiety symptoms during the past week. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.	12month follow up period
Secondary	Parkinson's Disease Questionnaire - 39 (PDQ39)	The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life. The measure is scored between 0 - 100 with 0 meaning no health problems and 100 meaning more health problems.	12month follow up period
Secondary	Non-Motor Symptoms Scale (NMSS)	Symptoms assessed over the last month. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. The measure is scored between 0 - 360, with 0 meaning there are no non-motor symptoms and 360 meaning there are non-motor symptoms.	12month follow up period