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Completed

NCT Number: NCT03050385

Cognitive Rehabilitation During Transcranial Direct Current Stimulation

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.

Completed

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Primary outcomes

  1. Attrition rate due to adverse events

    Time frame: up to two weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Center of Neurology and Psychiatry, Japan

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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