Study of tDCS for Mild Cognitive Impairment

August 7, 2018 updated by: Yong An Chung, Incheon St.Mary's Hospital

A Study for the Short- and Long-term Improvement of Cognitive Function (Evaluated by PET-CT and SNSB) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment

The primary objective of this study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have a subjective memory impairment
  • Subjects who have Korean version of Mini Mental Status Examination score 22 or more
  • Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
  • Subjects who have had other cognitive impairments besides memory
  • Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
  • Subjects who are not dementia of Alzheimer's type
  • Subjects who are right-handed
  • Subjects who are able to read and write
  • Subject or legally responsible caregiver has provided informed consent

Exclusion Criteria:

  • Subjects who have a history of stroke and seizures
  • Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a treatment ischemic attack.
  • Subjects who have neurologic problems on physical examination that cuase memory disturbances
  • Subjects who have a history of DSM-IV Axis I disorders
  • Subjects who have extremely sensitive skin
  • Subjects who have suffered from the cancer in 3 years
  • Subjects who have had a cerebrovascular neurosurgery in medical history
  • Subjects who have dyspnea in sitting position
  • Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
  • Subjects who have a history of drug or alcohol abuse (in the past 5 years)
  • Subjects who have a history of mental or emotional disorders (in the past 5 years)
  • Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia
  • Subjects who have a history of hospitalization due to head injury
  • Subjects who are unable to read even with glasses
  • Subject who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YBand (YDT-201N)
transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications)
Device: YBand (YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Sham Comparator: sham-Yband (YDT-201N)
sham-tDCS application 3 days a week for 12 weeks (total of 36 applications)
Device: sham-YBand (YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PET-CT images
Time Frame: from baseline to Week 12
from baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive function
Time Frame: from baseline to Week 12
Measured by SNSB
from baseline to Week 12
Change in Cognitive function
Time Frame: from baseline to Week 12
Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)
from baseline to Week 12
Change in activities of daily living
Time Frame: from baseline to Week 12
Measured by B-ADL
from baseline to Week 12
Change in Geriatric Depression Scale
Time Frame: from baseline to Week 12
from baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incheon St.Mary's Hospital

Collaborators

Ybrain Inc.

Investigators

  • Principal Investigator: Yong-An Chung, M.D., Ph.D., Professor, Department of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC14OISI0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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