Neurocognitive Disorders, Transcranial Direct Current Stimulation
Conditions
Keywords
cognitive rehabilitation
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.
Interventions
DEVICEtranscranial direct current stimulation
Sponsors
National Center of Neurology and Psychiatry, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attrition rate due to adverse events | up to two weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference of the mini mental state examination | up to four weeks | mini mental state examination |
| difference of Clinical Dementia Rating scale - sum of boxes | up to four weeks | Clinical Dementia Rating Scale - sum of boxes |
| difference of Alzheimer Disease Assessment Scale -Cognitive subscale | up to four weeks | Alzheimer's Disease Assessment Scale - cognitive subscale |
| Attrition rate for any reason | up to four weeks | — |
| difference of Frontal Assessment Battery | up to four weeks | — |
| difference of Mini Mental State Examination | up to four weeks | — |
Countries
Japan
Outcome results
None listed