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OpenTrials
Completed

NCT Number: NCT06814873

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

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.

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Key information

Conditions

Somatosensory Evoked Potentials, and Electroencephalography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keio University

Yokohama, Kanagawa, 223-8522, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • History of neurological disorder

Treatment and study plan

Neurofeedback

Behavioral

The participants received visual feedback of the processed result of neural signals acquired online.

Sham-feedback

Behavioral

Previously recorded neural signals are processed and presented to participants as if the signals from them are processed online.

Primary outcomes

  1. Somatosensory evoked potential

    Time frame: 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 outcomes

  1. Touch typing performance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Keio University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.