Back to resultsEffect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS and tDCS
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dual-mode group
rTMS group
Arm Description
the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
high-frequency rTMS and sham tDCS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02850159
Brief Title
Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Official Title
Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dual-mode group
Arm Type
Experimental
Arm Description
the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously
Arm Title
rTMS group
Arm Type
Active Comparator
Arm Description
high-frequency rTMS and sham tDCS
Intervention Type
Device
Intervention Name(s)
rTMS and tDCS
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of Freezing of Gait Questionnaire (FOG-Q)
Description
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.
Time Frame
Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28193533
Citation
Chang WH, Kim MS, Park E, Cho JW, Youn J, Kim YK, Kim YH. Effect of Dual-Mode and Dual-Site Noninvasive Brain Stimulation on Freezing of Gait in Patients With Parkinson Disease. Arch Phys Med Rehabil. 2017 Jul;98(7):1283-1290. doi: 10.1016/j.apmr.2017.01.011. Epub 2017 Feb 11.
Results Reference
derived
Learn more about this trial
Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
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