Gait, Rigid, Parkinson Disease
Conditions
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.
Interventions
PROCEDURETranscutaneous spinal cord stimulation
Theta burst stimulation at thoracic level (T5) over 2 minutes
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed