Tokyo, Aug. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062604) titled 'Optical evaluation of TMS-induced finger movements using Leap Motion 2' 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 - International University of Health and Welfare

Condition: Condition - Not applicable (basic research in healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Validation of a novel optical motion-capture method (Leap Motion 2) for measurement (method/device evaluation) Basic objectives2 - Others

Intervention: Interventions/Control_1 - (Studies 1-5: single-arm, non-randomized, self-controlled, open-label. Each targets n=20; overlap across sub-studies permitted [total TBD, see "4. Eligibility"]. Each = one 1.5-2h session.)

Study1(n=20): Optical recording of TMS(M1)-induced finger movement via Leap Motion 2, with simultaneous surface EMG MEP(FDI). Single-pulse TMS 120%RMT, 30 pulses q5-7s. Evaluates MEP-movement delay (electromechanical delay) and MEP amplitude-index finger movement correlation.

Study2(n=20): Simultaneous Leap Motion kinematics and multichannel MEP (3-5ch: APB,FDI,ADM,FDS,EDC) at 120%RMT, 30 pulses. Evaluates inter-finger movement-MEP relations to determine optimal muscle placement.

Study3(n=20): Using Study2 setup, compares TMS intensities 100/120/140%RMT (30 pulses each, 90 total).

Study4(n=20): Using Study2 setup, (4-1) coil orientation PA vs AP (30 each, 60 total); (4-2) rest vs mild contraction 10-20%MVC (30 each, 60 total).

Study5(n=20): Electrical stim (3x sensory threshold) to index/little finger, M1 TMS 23ms later (SAI). TMS-only/index-paired/little-paired, 30 each, 90 total.

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 obtaining consent [2] Able to provide voluntary written informed consent Key exclusion criteria - [1] Individuals receiving ongoing treatment for, or with a history of, neurological or psychiatric disease (excluding febrile seizures) [2] Individuals with relative contraindications to TMS (e.g., intracranial metal foreign body, implanted electronic device, history of epilepsy, pregnant or possibly pregnant women) [3] Individuals with musculoskeletal disease of both upper limbs (e.g., fracture, burn) [4] Individuals with apparent motor or sensory impairment of the fingers [5] Individuals with metabolic abnormalities due to internal medical conditions (e.g., cancer, chronic hepatitis) for whom an effect on cognitive/neurological function cannot be ruled out [6] Other individuals judged by the principal investigator to be inappropriate for participation Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 15 Day Date of IRB - 2026 Year 06 Month 26 Day Anticipated trial start date - 2026 Year 08 Month 24 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=R000071663

Disclaimer: Curated by HT Syndication.