Cognitive Rehabilitation During Transcranial Direct Current Stimulation
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ClinicalTrials.gov Identifier: NCT03050385 |
Recruitment Status :
Completed
First Posted : February 10, 2017
Last Update Posted : February 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Transcranial Direct Current Stimulation Neurocognitive Disorders | Device: transcranial direct current stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients |
Study Start Date : | October 2016 |
Actual Primary Completion Date : | July 28, 2017 |
Actual Study Completion Date : | August 18, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: active stimulation during cognitive rehabilitation
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 |
Device: transcranial direct current stimulation |
Sham Comparator: sham stimulation during cognitive rehabilitation
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 |
Device: transcranial direct current stimulation |
- Attrition rate due to adverse events [ Time Frame: up to two weeks ]
- difference of Alzheimer Disease Assessment Scale -Cognitive subscale [ Time Frame: up to four weeks ]Alzheimer's Disease Assessment Scale - cognitive subscale
- difference of the mini mental state examination [ Time Frame: up to four weeks ]mini mental state examination
- difference of Clinical Dementia Rating scale - sum of boxes [ Time Frame: up to four weeks ]Clinical Dementia Rating Scale - sum of boxes
- difference of Mini Mental State Examination [ Time Frame: up to four weeks ]
- Attrition rate for any reason [ Time Frame: up to four weeks ]
- difference of Frontal Assessment Battery [ Time Frame: up to four weeks ]

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Ages Eligible for Study: | 55 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- participants with a diagnosis of either major neurocognitive disorder or mild neurocognitive disorder, defined in Diagnostic and Statistical Manual of Mental disorder (DSM-5)
- taking the stable dose of psychotropic medication, such as cholinesterase inhibitors or NMDA(N-methyl-D-aspartate) receptor antagonist, for the past two weeks
- ambulant by oneself with or without aiding devices.
Exclusion Criteria:
- with severe psychotic symptoms requiring antipsychotic treatment
- with risks of hospitalization within 6 weeks because of severe depression and/or suicide ideation
- clinically contraindicated to electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
- with the Mini-Mental State Examination (MMSE) score of less than 18 or the Clinical Dementia Rating Scale (CDR) score of more than 2,
- unable to participate for more than 2 days during the trial
- unable to write a sentence or copy a figure on MMSE at screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050385
Japan | |
National Center of Neurology and Psychiatry | |
Kodaira, Tokyo, Japan, 187-8551 |
Principal Investigator: | Yuma Yokoi, MD | NCNP Japan |
Responsible Party: | National Center of Neurology and Psychiatry, Japan |
ClinicalTrials.gov Identifier: | NCT03050385 |
Other Study ID Numbers: |
A2016-048 |
First Posted: | February 10, 2017 Key Record Dates |
Last Update Posted: | February 26, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
cognitive rehabilitation |
Neurocognitive Disorders Mental Disorders |