rTMS Treatment in Vascular Parkinsonism (rTMS)
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|ClinicalTrials.gov Identifier: NCT03720691|
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Vascular Parkinsonism||Device: Real rTMS Supplementary motor area Device: Sham rTMS Supplementary motor area||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Real rTMS Supplementary motor area
Real rTMS will be applied over the supplementary motor area
Device: Real rTMS 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 Name: Real repetitive transcranial magnetic stimulation
Sham Comparator: Sham rTMS Supplementary motor area
Sham rTMS will be applied over the supplementary motor area
Device: Sham rTMS Supplementary motor area
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Other Name: Sham repetitive transcranial magnetic stimulation
- 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.
- 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.
- 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.
- The completion time during the SWS test [ Time Frame: 2 days ]The completion time will be recorded.
- Freezing episodes of gait trajectory [ Time Frame: 2 days ]The number of freezing episodes during rapid full turns and dual task
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720691
|Contact: Sang Jin Kim, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Inje university, Busan Paik Hospital|
|Busan, Korea, Republic of|
|Principal Investigator:||Sang Jin Kim, MD, PhD||Inje Unversity, Busan Paik Hospital|