Cognitive Rehabilitation During Transcranial Direct Current Stimulation

Not Applicable

Completed

• Conditions: Neurocognitive Disorders; Transcranial Direct Current Stimulation
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT03050385
• Lead Sponsor: National Center of Neurology and Psychiatry, Japan

Brief Summary

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

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-10
• Primary Completion: 2017-07-28
• Study Completion: 2017-08-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham stimulation during cognitive rehabilitation	transcranial direct current stimulation	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
active stimulation during cognitive rehabilitation	transcranial direct current stimulation	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

Primary Outcome Measures

Name	Time	Method
Attrition rate due to adverse events	up to two weeks

Secondary Outcome Measures

Name	Time	Method
difference of Clinical Dementia Rating scale - sum of boxes	up to four weeks	Clinical Dementia Rating Scale - sum of boxes
difference of the mini mental state examination	up to four weeks	mini mental state examination
Attrition rate for any reason	up to four weeks
difference of Frontal Assessment Battery	up to four weeks
difference of Alzheimer Disease Assessment Scale -Cognitive subscale	up to four weeks	Alzheimer's Disease Assessment Scale - cognitive subscale
difference of Mini Mental State Examination	up to four weeks

Trial Locations

Locations (1)

National Center of Neurology and Psychiatry; 🇯🇵 Kodaira, Tokyo, Japan