Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).

Detailed Description
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Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.

Official Title
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Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: rTMS and tDCS
* Device: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed as Parkinson's disease (PD) with freezing of gait walk independently without walking devices Exclusion Criteria: pre-existing and active major neurological diseases other than PD a previous history of seizures implanted metallic objects that would contraindicate rTMS

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dual-mode group<br>the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously | Device: rTMS and tDCS<br>* Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously<br>|
| Active Comparator: rTMS group<br>high-frequency rTMS and sham tDCS | Device: rTMS<br>* Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Freezing of Gait Questionnaire (FOG-Q) | Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome. | Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5 |