Cognitive Rehabilitation During Transcranial Direct Current Stimulation

NCT ID: NCT03050385

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-08-18

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.

Conditions

Transcranial Direct Current Stimulation; Neurocognitive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Interventions

transcranial direct current stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Neurology and Psychiatry, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuma Yokoi, MD

Role: PRINCIPAL_INVESTIGATOR

NCNP Japan

Locations

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31555109 (View on PubMed)

Other Identifiers

A2016-048

Identifier Type: -

Identifier Source: org_study_id