Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity
1 other identifier
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedFirst Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedFebruary 7, 2025
February 1, 2025
11 months
January 29, 2025
February 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Somatosensory evoked potential
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 Outcomes (1)
Touch typing 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.
Study Arms (2)
Verum
EXPERIMENTALParticipants in the group received real-time feedback of their own electroencephalogram signal
Sham
SHAM COMPARATORParticipants in the group received feedback of electroencephalogram signal previously recorded from other participants.
Interventions
The participants received visual feedback of the processed result of neural signals acquired online.
Previously recorded neural signals are processed and presented to participants as if the signals from them are processed online.
Eligibility Criteria
You may not qualify if:
- History of neurological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keio Universitylead
Study Sites (1)
Keio University
Yokohama, Kanagawa, 223-8522, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 7, 2025
Study Start
May 10, 2023
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
February 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share