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

Keio University

Status: Completed

Conditions: Somatosensory Evoked Potentials, and Electroencephalography

Treatments: Behavioral: Sham-feedback; Behavioral: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06814873

2023-128

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• History of neurological disorder

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Verum

Experimental group

Description:

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

Treatment:

Behavioral: Neurofeedback

Sham

Sham Comparator group

Description:

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

Treatment:

Behavioral: Sham-feedback