Back to resultsRepetitive Transcranial Magnetic Stimulation for Freezing of Gait
Primary Purpose
Parkinsonian Disorders
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rTMS Motor cortex
rTMS Supplementary motor area
Sponsored by
About this trial
This is an interventional treatment trial for Parkinsonian Disorders
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease or Primary progressive freezing of gait
- age 18 and older
- Freezing of gait
Exclusion Criteria:
- pregnant or any, other medical, surgical, neurological or psychiatric conditions
- other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
- any past or current history of seizure disorder or epilepsy
- unable to give informed consent
Sites / Locations
- Dongtan Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rTMS Motor cortex
rTMS Supplementary motor area
Arm Description
rTMS will be applied over the motor cortex
rTMS will be applied over the supplementary motor area
Outcomes
Primary Outcome Measures
The number of steps
The number of steps during the stand-walk-sit (SWS) test
Secondary Outcome Measures
The completion time during the SWS test
Freezing episodes of gait trajectory
Patient and Clinical Global Impression Scale
Full Information
NCT ID
NCT01853150
First Posted
May 10, 2013
Last Updated
July 23, 2018
Sponsor
Dongtan Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01853150
Brief Title
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Official Title
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongtan Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonian Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rTMS Motor cortex
Arm Type
Experimental
Arm Description
rTMS will be applied over the motor cortex
Arm Title
rTMS Supplementary motor area
Arm Type
Active Comparator
Arm Description
rTMS will be applied over the supplementary motor area
Intervention Type
Device
Intervention Name(s)
rTMS Motor cortex
Intervention Type
Device
Intervention Name(s)
rTMS Supplementary motor area
Primary Outcome Measure Information:
Title
The number of steps
Description
The number of steps during the stand-walk-sit (SWS) test
Time Frame
2 days
Secondary Outcome Measure Information:
Title
The completion time during the SWS test
Time Frame
2 days
Title
Freezing episodes of gait trajectory
Time Frame
2 days
Title
Patient and Clinical Global Impression Scale
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease or Primary progressive freezing of gait
age 18 and older
Freezing of gait
Exclusion Criteria:
pregnant or any, other medical, surgical, neurological or psychiatric conditions
other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
any past or current history of seizure disorder or epilepsy
unable to give informed consent
Facility Information:
Facility Name
Dongtan Sacred Heart Hospital
City
Hwaseong Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
445-170
Country
Korea, Republic of
12. IPD Sharing Statement
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Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
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