- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853150
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
July 23, 2018 updated by: Suk Yun Kang, Dongtan Sacred Heart Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-Do
-
Hwaseong Si, Gyeonggi-Do, Korea, Republic of, 445-170
- Dongtan Sacred Heart Hospital
-
-
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rTMS Motor cortex
rTMS will be applied over the motor cortex
|
|
Active Comparator: rTMS Supplementary motor area
rTMS will be applied over the supplementary motor area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of steps
Time Frame: 2 days
|
The number of steps during the stand-walk-sit (SWS) test
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The completion time during the SWS test
Time Frame: 2 days
|
2 days
|
Freezing episodes of gait trajectory
Time Frame: 2 days
|
2 days
|
Patient and Clinical Global Impression Scale
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2013
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
May 10, 2013
First Submitted That Met QC Criteria
May 10, 2013
First Posted (Estimate)
May 14, 2013
Study Record Updates
Last Update Posted (Actual)
July 24, 2018
Last Update Submitted That Met QC Criteria
July 23, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-022 (Scottsdale Healthcare IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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