Tokyo, June 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062062) titled 'Elucidation of Interhemispheric Interaction Mechanisms Using Somatosensory Evoked Potential Testing' on June 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyorin University School of Medicine

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

Objective: Narrative objectives1 - 1. Determine the threshold inter-stimulus interval (ISI) at which preceding contralateral stimulation ceases to affect the SEP waveforms (latency, amplitude, and morphology) of the test stimulus. 2. Compare SEPs elicited by upper-limb (median nerve) and lower-limb (tibial nerve) stimulation to examine differences in site-specific characteristics. 3. Validate the alternating left-right stimulation method and contribute to its appropriate application in clinical neurophysiological testing, rehabilitation research, and intraoperative monitoring. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - Although this is actually a single-blind randomized trial in which the antecedent stimulus is varied randomly for each subject, data entry is not possible due to a system bug.

The following procedures were performed on the median and tibial nerves (stimulation frequency: 2 Hz)

Upper and lower limbs: 8 conditions (A) Right only, (A') Left only, (B) Simultaneous, (C) ISI = 20 ms, (D) 50 ms, (E) 100 ms, (F) 150 ms, (G) 250 ms (alternating left and right)

Additional conditions for lower limbs only: 4 conditions (B') 10 ms, (B'') 15 ms, (C') 25 ms, (C'') 30 ms

Total: 16 conditions (upper and lower limbs) + 4 conditions (lower limbs only) = 20 conditions

9-5. Stimulation parameters

Median nerve: 10 mA or less (intensity causing slight thumb movement) Tibial nerve: 20 mA or less (intensity causing slight toe movement)

Analysis time: -110 to 190 ms Frequency band: 2-2,000 Hz Signal averaging: 500 trials

Each condition takes approximately 5 minutes, resulting in a total measurement time of approximately 90 minutes (proceeding from left to right in the figure below).

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy adults aged 18-50 2. Right-handed (LQ equal or more than 40 on the Edinburgh Handedness Inventory) 3. Individuals capable of voluntarily consenting to participate in the study 4. Individuals with no history of neurological abnormalities Key exclusion criteria - History of central nervous system disorders or peripheral neuropathy Metal plates implanted at the stimulation site Implanted medical devices such as pacemakers Use of medications affecting the nervous system Pregnancy or potential pregnancy Skin conditions making it difficult to attach stimulation electrodes Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 02 Day Date of IRB - 2026 Year 02 Month 05 Day Anticipated trial start date - 2026 Year 06 Month 01 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=R000071014

Disclaimer: Curated by HT Syndication.