Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity

Not Applicable

Completed

• Conditions: Somatosensory Evoked Potentials, and Electroencephalography

• Registration Number: NCT06814873
• Lead Sponsor: Keio University

Brief Summary

The purpose of this study is to examine the functional and structural modification effects on the brain of a non-invasive experimental device applied to the head and forearms of healthy subjects during motor recall training. The experimental device used in this study is the Brain-Machine Interface (hereinafter referred to as BMI), which is under development in the principal investigator's laboratory. The BMI consists of an arithmetic unit that processes the results in real time using a personal computer, a depth ray that displays the results, a transcutaneous electrical stimulator that is driven based on the results of the arithmetic, and an exoskeletal motor assist device that is driven based on the results of the arithmetic.

Detailed Description

This study does not fall under the category of 'medical research involving human subjects' or 'clinical research subject to legal regulations' in Japan, and the appointment of a principal investigator (PI) is not required. For the convenience of registry submission, the name of the principal investigator field has been filled with the name of the study representative (a non-physician).

Study Timeline

• Study Start: 2023-05-10
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Study First Submitted: 2025-01-29
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

• History of neurological disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Somatosensory evoked potential	From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.	Median nerve stimulation elicits the somatosensory evoked potentials. Their amplitude was calculated.

Secondary Outcome Measures

Name	Time	Method
Touch typing performance	From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.	A touch typing task was employed to test sensorimotor integration performance

Trial Locations

Locations (1)

Keio University; 🇯🇵 Yokohama, Kanagawa, Japan