Transcutaneous Spinal Cord Stimulation for Parkinson Disease

Not Applicable

• Conditions: Gait, Rigid; Parkinson Disease
• Interventions: Procedure: Transcutaneous spinal cord stimulation

• Registration Number: NCT04171076
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2019-10-15
• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Primary Completion: 2019-11-15
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Transcutaneous spinal cord stimulation	Intervention: non-invasive spinal cord stimulation

Primary Outcome Measures

Name	Time	Method
Freezing of gait score	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 Outcome Measures

Name	Time	Method
Gait speed	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.
Freezing of gait questionnaire	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
Safety of the intervention - urinary incontinence	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.
Safety of the intervention - lower limb strength.	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.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil