NCT06322797

The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement

A Randomized, Controlled, Patient- and Assessor- Blinded, Exploratory Clinical Trial to Search the Stimulation Site for Repetitive Transcranial Magnetic Stimulation (rTMS) That Improves Upper Extremity Function After Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: MinYoung Kim, MD, PhD · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes. However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment. Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields. Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities. The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: South Korea