Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
April 16, 2024 updated by: Yun-Hee Kim, Samsung Medical Center
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dual-mode group
the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
|
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
|
|
Active Comparator: rTMS group
high-frequency rTMS and sham tDCS
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Freezing of Gait Questionnaire (FOG-Q)
Time Frame: 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.
|
Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 22, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimated)
July 29, 2016
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-09-122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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