Cognitive Rehabilitation During Transcranial Direct Current Stimulation

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

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.

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders; Transcranial Direct Current Stimulation
• Intervention / Treatment: Device: transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Kodaira, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Center of Neurology and Psychiatry, Japan
• Investigators: Principal Investigator: Yuma Yokoi, MD, NCNP Japan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): August 18, 2017

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cognitive rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: A2016-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO