Cognitive Rehabilitation During Transcranial Direct Current Stimulation

• Sponsor: National Center of Neurology and Psychiatry, Japan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03050385
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 10.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transcranial Direct Current Stimulation; Neurocognitive Disorders	Device: transcranial direct current stimulation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jul 28, 2017
• Actual Study Completion Date: Aug 18, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: transcranial direct current stimulation
Sham Comparator: 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	Device: transcranial direct current stimulation

Outcome Measures

Primary Outcome Measures

1. Attrition rate due to adverse events [up to two weeks]

Secondary Outcome Measures

1. difference of Alzheimer Disease Assessment Scale -Cognitive subscale [up to four weeks]

   Alzheimer's Disease Assessment Scale - cognitive subscale

2. difference of the mini mental state examination [up to four weeks]

   mini mental state examination

3. difference of Clinical Dementia Rating scale - sum of boxes [up to four weeks]

   Clinical Dementia Rating Scale - sum of boxes

4. difference of Mini Mental State Examination [up to four weeks]

5. Attrition rate for any reason [up to four weeks]

6. difference of Frontal Assessment Battery [up to four weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center of Neurology and Psychiatry	Kodaira	Tokyo	Japan	187-8551

Sponsors and Collaborators

• National Center of Neurology and Psychiatry, Japan

Investigators

• Principal Investigator: Yuma Yokoi, MD, NCNP Japan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Center of Neurology and Psychiatry, Japan
• ClinicalTrials.gov Identifier: NCT03050385
• Other Study ID Numbers: A2016-048
• First Posted: Feb 10, 2017
• Last Update Posted: Feb 26, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by National Center of Neurology and Psychiatry, Japan: cognitive rehabilitation
• Additional relevant MeSH terms: Neurocognitive Disorders

Study Results

No Results Posted as of Feb 26, 2020