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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: rTMS and tDCS; Device: rTMS

• Registration Number: NCT02850159
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-29
• Results First Submitted: 2017-04-24
• Results First Submitted QC: 2017-05-31
• Results First Posted: 2017-07-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• diagnosed as Parkinson's disease (PD) with freezing of gait
• walk independently without walking devices

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Exclusion Criteria

• pre-existing and active major neurological diseases other than PD
• a previous history of seizures
• implanted metallic objects that would contraindicate rTMS

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dual-mode group	rTMS and tDCS	the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
rTMS group	rTMS	high-frequency rTMS and sham tDCS

Primary Outcome Measures

Name	Time	Method
Change of Freezing of Gait Questionnaire (FOG-Q)	Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5	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.