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The purpose of this study is to explore whether active transcranial direct current stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without severe side effects in mild cognitive impairment or mild dementia patients.
This study explores the additive effect of transcranial direct stimulation compared to sham stimulation during cognitive rehabilitation tasks in mild cognitive impairment or mild dementia patients. Potential participants are recruited by physicians' referral or self-entry. Informed consent by a clinical research coordinator and research physician is performed followed by screening. Participants who passed screening go through 10 sessions of active or sham transcranial direct current stimulation and are evaluated their cognitive function at screening, at the end, and two weeks after the intervention. For quality assurance, independent researcher regularly monitor and audit as participants are enrolled in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active stimulation during cognitive rehabilitation | Active Comparator | active transcranial direct current stimulation 20 minutes per session twice a day interval between sessions: more than 20 minutes 7 cm x 5 cm electrodes anodal electrode on F3 cathodal electrode on right forehead 2 mA(milliampere) cognitive rehabilitation 10-minute calculation task followed by 10-minute task of local (Japanese) language test |
|
| sham stimulation during cognitive rehabilitation | Sham Comparator | sham transcranial direct current stimulation 20 minutes per session twice a day interval between sessions: more than 20 minutes 7 cm x 5 cm electrodes anodal electrode on F3 cathodal electrode on right forehead 2 mA cognitive rehabilitation 10-minute calculation task followed by 10-minute task of local (Japanese) language test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attrition rate due to adverse events | up to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| difference of Alzheimer Disease Assessment Scale -Cognitive subscale | Alzheimer's Disease Assessment Scale - cognitive subscale | up to four weeks |
| difference of the mini mental state examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuma Yokoi, MD | NCNP Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Neurology and Psychiatry | Kodaira | Tokyo | 187-8551 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31555109 | Derived | Inagawa T, Yokoi Y, Narita Z, Maruo K, Okazaki M, Nakagome K. Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. Front Hum Neurosci. 2019 Sep 6;13:273. doi: 10.3389/fnhum.2019.00273. eCollection 2019. |
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| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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mini mental state examination
| up to four weeks |
| difference of Clinical Dementia Rating scale - sum of boxes | Clinical Dementia Rating Scale - sum of boxes | up to four weeks |
| difference of Mini Mental State Examination | up to four weeks |
| Attrition rate for any reason | up to four weeks |
| difference of Frontal Assessment Battery | up to four weeks |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |