Tokyo, Aug. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062602) titled 'Development and Evaluation of a Pressure Distribution Assessment System for Stable Transcranial Magnetic Stimulation' on Aug. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Department of Pharmacy, Faculty of Pharmaceutical Sciences, Fukuoka

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To develop a system that quantitatively evaluates, as a pressure distribution, whether the center of a transcranial magnetic stimulation (TMS) coil is in close contact with the scalp, using pressure sensors attached to the coil. The study evaluates whether real-time feedback of this pressure distribution stabilizes coil positioning and enables more stable recording of motor evoked potentials (MEPs). Basic objectives2 - Others

Intervention: Interventions/Control_1 - Study 1: A TMS coil fitted with pressure sensors is held over the left primary motor cortex hotspot for 3 minutes, and variation in the pressure distribution and center of pressure is recorded. No magnetic stimulation is delivered; only coil positioning is performed. Sensor configurations of 3 (standard), 4 and 6 sensors are compared. Study 2: Single-pulse TMS is delivered to the left primary motor cortex hotspot at 120% of the resting motor threshold, once every 5-7 seconds, in 3-5 blocks of 20 pulses (60-100 pulses in total). Blocks alternate between pressure-distribution feedback on or off, and MEPs are recorded from the right first dorsal interosseous muscle by surface electromyography. Study 3: Using an optical neuronavigation system (Brainsight), markers are placed on the TMS coil and on the scalp, and the displacement of the center of pressure from the coil center and the coil tilt are measured in real time to evaluate their correlation.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Healthy adult men and women aged 18 to 64 years at the time of consent. 2) Able to provide written informed consent of their own free will. Key exclusion criteria - 1) Ongoing treatment for, or a history of, neurological or psychiatric disease (e.g. a history of febrile seizures). 2) Pregnant or possibly pregnant women. 3) Cancer, chronic hepatitis or other internal disease with metabolic abnormality that may affect brain function. 4) Implanted electrical stimulation devices such as a pacemaker, or implanted metal. 5) Uncontrolled bleeding. 6) Any other reason judged by the principal investigator to make participation inappropriate. Target Size - 27

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 01 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 06 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071662

Disclaimer: Curated by HT Syndication.