NCT03050385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

January 3, 2017

Last Update Submit

February 24, 2020

Conditions

Transcranial Direct Current StimulationNeurocognitive Disorders

Keywords

cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Attrition rate due to adverse events

    up to two weeks

Secondary Outcomes (6)

  • difference of Alzheimer Disease Assessment Scale -Cognitive subscale

    up to four weeks

  • difference of the mini mental state examination

    up to four weeks

  • difference of 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

  • +1 more secondary outcomes

Study Arms (2)

active stimulation during cognitive rehabilitation

ACTIVE COMPARATOR

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 stimulation during cognitive rehabilitation

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulationDEVICE
active stimulation during cognitive rehabilitationsham stimulation during cognitive rehabilitation

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31555109DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Yuma Yokoi, MD

    NCNP Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

February 10, 2017

Study Start

October 1, 2016

Primary Completion

July 28, 2017

Study Completion

August 18, 2017

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)