The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement
NCT06322797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-03-21
Summary
A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.
Conditions
Interventions
- DEVICE
-
rTMS
Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of \> 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval. Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min.
- DEVICE
-
rTMS
Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. After identifying the brain site that is activated during finger tapping during fMI, Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. the resting motor threshold was measured for each patient at target brain site.
- DEVICE
-
Sham
In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups.
Sponsors & Collaborators
-
MinYoung Kim, MD, PhD
lead OTHER
Principal Investigators
-
Kim MinYoung, M.D., Ph.D. · CHA University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-19
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- South Korea
Study Locations
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