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CompletedNCT06814873Updated Feb 7, 2025

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

An interventional study of Neurofeedback and Sham-feedback in Somatosensory Evoked Potentials, and Electroencephalography, sponsored by Keio University. Completed at 1 site in Japan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Keio University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled May 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Somatosensory Evoked Potentials, and Electroencephalography
03

In context

Lead sponsor

Keio University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Exclusion Criteria:

  • History of neurological disorder
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Verum

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

    Behavioral: Neurofeedback

  • Sham comparator
    Sham

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

    Behavioral: Sham-feedback

Interventions

  • BehavioralNeurofeedback

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

  • BehavioralSham-feedback

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

06

What researchers measure

Primary outcomes

  1. Somatosensory evoked potential

    Median nerve stimulation elicits the somatosensory evoked potentials. Their amplitude was calculated.

    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.

Secondary outcomes

  1. Touch typing performance

    A touch typing task was employed to test sensorimotor integration 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.

07

Study locations

1 site
  • Keio University
    Yokohama, Kanagawa 223-8522, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06814873
Lead sponsor
Keio University
Responsible party
Junichi Ushiba (Professor, Keio University) — Principal investigator
First posted
Feb 7, 2025
Start date
May 10, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Feb 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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