Transcutaneous Spinal Cord Stimulation for Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171076
• Other study ID #: USaoPauloGH 1
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: November 30, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Rigid
• Parkinson Disease

Intervention

Procedure:
• Transcutaneous spinal cord stimulation
Theta burst stimulation at thoracic level (T5) over 2 minutes

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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