Cognitive Rehabilitation During Transcranial Direct Current Stimulation

National Center of Neurology and Psychiatry, Japan

Status: Completed

Conditions: Transcranial Direct Current Stimulation; Neurocognitive Disorders

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03050385

A2016-048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

active stimulation during cognitive rehabilitation

Active Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation

sham stimulation during cognitive rehabilitation

Sham Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation