- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03720691
rTMS Treatment in Vascular Parkinsonism (rTMS)
Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.
Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sang Jin Kim, MD, PhD
- Phone Number: 82-51-890-8954
- Email: jsk120@hanmail.net
Study Locations
-
-
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Busan, Korea, Republic of
- Inje university, busan paik hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Vascular parkinsonism
- age 18 and older
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Real rTMS Supplementary motor area
Real rTMS will be applied over the supplementary motor area
|
There will be a series of four rTMS blocks separated by 10 minutes.
Each block will consist of 15 to 25 pulse trains of 1-second duration at 25 Hz, with an intertrain interval of 10 seconds.
Other Names:
|
Sham Comparator: Sham rTMS Supplementary motor area
Sham rTMS will be applied over the supplementary motor area
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There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)
Time Frame: 2 days
|
Motor functions will be checked using UPDRS.
Each item of the motor part ranges from 0 to 4 (0 means normal, 4 means worst condition).
Total sum will be calculated.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finger tapping test with right hand
Time Frame: 2 days
|
Finger tapping test with right hand, as quickly as possible for 15 second.
The total number of taps will be calculated.
The test will be twice with one minute interval.
After the test performed twice, the average of the tests will be used.
|
2 days
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The total number of steps during the stand-walk-sit (SWS) test
Time Frame: 2 days
|
SWS test is Standing up, making a 9 m round trip, and sitting down as quickly as possible.
The number of steps will be recorded.
|
2 days
|
The completion time during the SWS test
Time Frame: 2 days
|
The completion time will be recorded.
|
2 days
|
Freezing episodes of gait trajectory
Time Frame: 2 days
|
The number of freezing episodes during rapid full turns and dual task
|
2 days
|
Patient and Clinical Global Impression Scale
Time Frame: 2 days
|
7-point scale that requires the patient (or clinician) to rate the response of the interventions.
The rating will be numbered (1: very much improved; 2: much improved; 3: minimally improved; 4: no changes; 5: minimally worse; 6: much worse; 7: very much worse).
|
2 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sang Jin Kim, MD, PhD, Inje Unversity, Busan Paik Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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