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

February 3, 2025 updated by: Junichi Ushiba, Keio University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 223-8522
        • Keio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Exclusion Criteria:

  • History of neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum
Participants in the group received real-time feedback of their own electroencephalogram signal
Behavioral: Neurofeedback
The participants received visual feedback of the processed result of neural signals acquired online.
Sham Comparator: Sham
Participants in the group received feedback of electroencephalogram signal previously recorded from other participants.
Behavioral: Sham-feedback
Previously recorded neural signals are processed and presented to participants as if the signals from them are processed online.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the timing of pre-training evaluation (before the intervention) to the end of evaluation (after the intervention), with the intervention lasting 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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