Cognitive Rehabilitation During Transcranial Direct Current Stimulation

National Center of Neurology and Psychiatry, Japan20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Transcranial Direct Current Stimulation Neurocognitive Disorders

Interventions

transcranial direct current stimulationDEVICE

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Outcomes

Primary Outcomes

Attrition rate due to adverse events

Time frame: up to two weeks

Secondary Outcomes

difference of Alzheimer Disease Assessment Scale -Cognitive subscale

Alzheimer's Disease Assessment Scale - cognitive subscale

Time frame: up to four weeks

difference of the mini mental state examination

mini mental state examination

Time frame: up to four weeks

difference of Clinical Dementia Rating scale - sum of boxes

Clinical Dementia Rating Scale - sum of boxes

Time frame: up to four weeks

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

Data from ClinicalTrials.gov

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