Clinical trial NCT03050385: 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
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Neurocognitive Disorders
Keywords: cognitive rehabilitation
Lead sponsor: National Center of Neurology and Psychiatry, Japan
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Attrition rate due to adverse events
timeFrame: up to two weeks
Secondary outcomes:
measure: difference of Alzheimer Disease Assessment Scale -Cognitive subscale
timeFrame: up to four weeks
measure: difference of the mini mental state examination
timeFrame: up to four weeks
measure: difference of Clinical Dementia Rating scale - sum of boxes
timeFrame: up to four weeks
measure: difference of Mini Mental State Examination
timeFrame: up to four weeks
measure: Attrition rate for any reason
timeFrame: up to four weeks
measure: difference of Frontal Assessment Battery
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
Study officials:
affiliation: NCNP Japan
name: Yuma Yokoi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.