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Cognitive Rehabilitation During Transcranial Direct Current Stimulation

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ClinicalTrials.gov Identifier: NCT03050385
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Center of Neurology and Psychiatry, Japan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Neurocognitive Disorders Device: transcranial direct current stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients
Study Start Date : October 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Attrition rate due to adverse events [ Time Frame: up to two weeks ]

Secondary Outcome Measures :
  1. difference of Alzheimer Disease Assessment Scale -Cognitive subscale [ Time Frame: up to four weeks ]
    Alzheimer's Disease Assessment Scale - cognitive subscale

  2. difference of the mini mental state examination [ Time Frame: up to four weeks ]
    mini mental state examination

  3. difference of Clinical Dementia Rating scale - sum of boxes [ Time Frame: up to four weeks ]
    Clinical Dementia Rating Scale - sum of boxes

  4. difference of Mini Mental State Examination [ Time Frame: up to four weeks ]
  5. Attrition rate for any reason [ Time Frame: up to four weeks ]
  6. difference of Frontal Assessment Battery [ Time Frame: up to four weeks ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050385


Locations
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Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Sponsors and Collaborators
National Center of Neurology and Psychiatry, Japan
Investigators
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Principal Investigator: Yuma Yokoi, MD NCNP Japan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Center of Neurology and Psychiatry, Japan
ClinicalTrials.gov Identifier: NCT03050385    
Other Study ID Numbers: A2016-048
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Center of Neurology and Psychiatry, Japan:
cognitive rehabilitation
Additional relevant MeSH terms:
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Neurocognitive Disorders
Mental Disorders