Transcranial Direct Current Stimulation for Freezing of Gait

Study Overview
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Brief Summary
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This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).

Official Title
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Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)
* Other: locomotor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18- 80 Parkinson's disease stages 2-3 Hoehn and Yahr. Presence of Freezing of Gait Stable medication regimen Time to complete TUG >12 seconds Exclusion Criteria: medical condition that would interfere with walking and training for 30 minutes unable to perform timed up and go in the off condition history of seizures implanted deep brain stimulator, pacemaker or any other electronic device. dementia Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS+ LT<br>Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.<br>* Other names: tDCS;Other: locomotor training<br>* An individualized dual-task walking program for approximately 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking Speed | walking speed will be measured using sensors during a 90 second walk | baseline, 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS motor score range from 0-56 with higher scores indicating greater impairment. | baseline, 3 weeks | 
| Change in Stride Length | Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk. | baseline, 3 weeks | 
| Change in Postural Sway | Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing. | baseline, 3 weeks | 
| Change in Timed Up-and-Go (TUG) Time | Participants are timed while standing up from a chair, walking around a cone, and returning to their chair. | baseline, 3 weeks | 
| Change in Motor Threshold | Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand. | baseline, 3 weeks | 
| Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio | Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS). | baseline, 3 weeks | 
| Change in Backward Digit Span | Digit span is measured by total number of correct digits recited. | baseline, 3 weeks | 
| Change in the Trail Making Test Time | Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment. | baseline, 3 weeks | 
| Change in the Montreal Cognitive Assessment (MOCA) | The MOCA has a total score ranging from 0-30 with a higher score indicating better performance. | baseline, 3 weeks | 
| Change in the Auditory Consonant Trigrams Test (ACT) | The ACT has a score from 0-60 with higher score indicating better performance. | baseline, 3 weeks | 
| Change in the Freezing of Gait Questionnaire (FOG-Q) | The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing. | baseline, 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, neuromodulation