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

NCT ID: NCT06814873

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-03-31

Brief Summary

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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

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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).

Conditions

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Somatosensory Evoked Potentials, and Electroencephalography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Verum

Participants in the group received real-time feedback of their own electroencephalogram signal

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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

Sham

Participants in the group received feedback of electroencephalogram signal previously recorded from other participants.

Group Type SHAM_COMPARATOR

Sham-feedback

Intervention Type BEHAVIORAL

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

Interventions

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Neurofeedback

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

Intervention Type BEHAVIORAL

Sham-feedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* History of neurological disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Keio University

OTHER

Sponsor Role lead

Responsible Party

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Junichi Ushiba

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Keio University

Yokohama, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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2023-128

Identifier Type: -

Identifier Source: org_study_id

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