Transcutaneous Spinal Cord Stimulation for Parkinson Disease

November 18, 2019 updated by: Rubens Gisbert Cury, University of Sao Paulo General Hospital

Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Recruiting
        • University of Sao Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freezing of gait score
Time Frame: One week
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
Time Frame: baseline, 1 week, 4 week
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
Time Frame: baseline, 1 week, 4 week
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
Time Frame: 1 week, 4 week
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.
Time Frame: 1 week, 4 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Anticipated)

November 15, 2019

Study Completion (Anticipated)

November 30, 2019

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USaoPauloGH 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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