Cognitive Rehabilitation During Transcranial Direct Current Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients

Conditions
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Transcranial Direct Current Stimulation, Neurocognitive Disorders

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active stimulation during cognitive rehabilitation<br>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<br> <br> |
| Sham Comparator: sham stimulation during cognitive rehabilitation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate due to adverse events |  | up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation