Cognitive Rehabilitation During Transcranial Direct Current Stimulation

Neurocognitive Disorders Clinical Trial

Official title:

COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050385
• Other study ID #: A2016-048
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 18, 2017

Study information

• Verified date: February 2020
• Source: National Center of Neurology and Psychiatry, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 18, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Disorders
• Transcranial Direct Current Stimulation

Intervention

Device:
• transcranial direct current stimulation

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Kodaira	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition rate due to adverse events		up to two weeks
Secondary	difference of Alzheimer Disease Assessment Scale -Cognitive subscale	Alzheimer's Disease Assessment Scale - cognitive subscale	up to four weeks
Secondary	difference of the mini mental state examination	mini mental state examination	up to four weeks
Secondary	difference of Clinical Dementia Rating scale - sum of boxes	Clinical Dementia Rating Scale - sum of boxes	up to four weeks
Secondary	difference of Mini Mental State Examination		up to four weeks
Secondary	Attrition rate for any reason		up to four weeks
Secondary	difference of Frontal Assessment Battery		up to four weeks