Transcutaneous Spinal Cord Stimulation for Parkinson Disease

Study Overview
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Brief Summary
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Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn.

Detailed Description
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Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn. In this pilot trial, the investigators recruit participants with Parkinson' disease and freezing of gait. The aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.

Official Title
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Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease

Conditions
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Gait, Rigid, Parkinson Disease

Intervention / Treatment
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* Procedure: Transcutaneous spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of advanced idiopathic Parkinson's disease significant freezing of gait despite optimized treatment with medications and rehabilitation program Exclusion Criteria: psychiatric symptoms dementia cardiac pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention: non-invasive spinal cord stimulation | Procedure: Transcutaneous spinal cord stimulation<br>* Theta burst stimulation at thoracic level (T5) over 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freezing of gait score | The primary outcome is the freezing of gait score. 12-item scale, each item scores 3 points at maximum; the score ranges from 0-36; higher scores mean higher severity | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Gait speed measured through the time to up and go - It uses the time that a person takes to rise from a chair, walk ten meters, turn around, walk back to the chair, and sit down. | baseline, 1 week, 4 week | 
| Freezing of gait questionnaire | The freezing of gait questionnaire assess the freezing of gait severity in 9-item scale ( ranging from 0-28 points); higher score mean higher severity | baseline, 1 week, 4 week | 
| Safety of the intervention - urinary incontinence | Incidence of Patients self report problems: urinary incontinence. The urinary incontinence will be measure through the Revised Urinary Incontinence Scale, ranging from 0 to 16. Higher scores mean higher the urinary symptoms. | 1 week, 4 week | 
| Safety of the intervention - lower limb strength. | Incidence of Patients self report problems: worsening in gait due to weakness. The lower limb strength will be measure through the neurologic exam. The force degree ranges from 0 - none, to 5 - normal strength. | 1 week, 4 week |