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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Participants in the group received real-time feedback of their own electroencephalogram signal |
|
| Sham | Sham Comparator | Participants in the group received feedback of electroencephalogram signal previously recorded from other participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Behavioral | The participants received visual feedback of the processed result of neural signals acquired online. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Touch typing performance | 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. |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keio University | Yokohama | Kanagawa | 223-8522 | Japan |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham-feedback | Behavioral | Previously recorded neural signals are processed and presented to participants as if the signals from them are processed online. |
|
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |