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Cognitive Rehabilitation During Transcranial Direct Current Stimulation

Primary Purpose

Transcranial Direct Current Stimulation, Neurocognitive Disorders

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
National Center of Neurology and Psychiatry, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation focused on measuring cognitive rehabilitation

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Center of Neurology and Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active stimulation during cognitive rehabilitation

sham stimulation during cognitive rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Attrition rate due to adverse events

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2017
Last Updated
February 24, 2020
Sponsor
National Center of Neurology and Psychiatry, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT03050385
Brief Title
Cognitive Rehabilitation During Transcranial Direct Current Stimulation
Official Title
COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center of Neurology and Psychiatry, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Neurocognitive Disorders
Keywords
cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active stimulation during cognitive rehabilitation
Arm Type
Active Comparator
Arm Description
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
Arm Title
sham stimulation during cognitive rehabilitation
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Attrition rate due to adverse events
Time Frame
up to two weeks
Secondary Outcome Measure Information:
Title
difference of Alzheimer Disease Assessment Scale -Cognitive subscale
Description
Alzheimer's Disease Assessment Scale - cognitive subscale
Time Frame
up to four weeks
Title
difference of the mini mental state examination
Description
mini mental state examination
Time Frame
up to four weeks
Title
difference of Clinical Dementia Rating scale - sum of boxes
Description
Clinical Dementia Rating Scale - sum of boxes
Time Frame
up to four weeks
Title
difference of Mini Mental State Examination
Time Frame
up to four weeks
Title
Attrition rate for any reason
Time Frame
up to four weeks
Title
difference of Frontal Assessment Battery
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuma Yokoi, MD
Organizational Affiliation
NCNP Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31555109
Citation
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.
Results Reference
derived

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Cognitive Rehabilitation During Transcranial Direct Current Stimulation

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