Transcutaneous Spinal Cord Stimulation for Parkinson Disease
Primary Purpose
Parkinson Disease, Gait, Rigid
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcutaneous spinal cord stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- University of São PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Intervention: non-invasive spinal cord stimulation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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.
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.
Full Information
NCT ID
NCT04171076
First Posted
November 10, 2019
Last Updated
November 18, 2019
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04171076
Brief Title
Transcutaneous Spinal Cord Stimulation for Parkinson Disease
Official Title
Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait, Rigid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention: non-invasive spinal cord stimulation
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous spinal cord stimulation
Intervention Description
Theta burst stimulation at thoracic level (T5) over 2 minutes
Primary Outcome Measure Information:
Title
Freezing of gait score
Description
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
Time Frame
One week
Secondary Outcome Measure Information:
Title
Gait speed
Description
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.
Time Frame
baseline, 1 week, 4 week
Title
Freezing of gait questionnaire
Description
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
Time Frame
baseline, 1 week, 4 week
Title
Safety of the intervention - urinary incontinence
Description
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.
Time Frame
1 week, 4 week
Title
Safety of the intervention - lower limb strength.
Description
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.
Time Frame
1 week, 4 week
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
aged 18 years or higher
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD
Phone
551126610000
Email
rubens_cury@usp.br
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Spinal Cord Stimulation for Parkinson Disease
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