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Clinical Trials/NCT04171076
NCT04171076
Unknown
Not Applicable

Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease

University of Sao Paulo General Hospital1 site in 1 country5 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Sao Paulo General Hospital
Enrollment
5
Locations
1
Primary Endpoint
Freezing of gait score
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
November 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rubens Gisbert Cury

Principal investigator

University of Sao Paulo General Hospital

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
  • cardiac pacemaker

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Gait speed(baseline, 1 week, 4 week)
  • Freezing of gait questionnaire(baseline, 1 week, 4 week)
  • Safety of the intervention - urinary incontinence(1 week, 4 week)
  • Safety of the intervention - lower limb strength.(1 week, 4 week)

Study Sites (1)

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