A Pilot Study of tDCS for Mild to Moderate Alzhemier's Disease

August 31, 2014 updated by: Duk Lyul Na, Samsung Medical Center

A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 11) After Transcranial Direct Current Stimulation in Mild to Moderate Alzheimer's Disease

The primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Alzheimer's disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Twenty 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 home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

  • Name: Duk-Lyul Na, MD, PhD
  • Phone Number: +82-2-3410-3594
  • Email: dukna@naver.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have Korean version of Mini Mental Status Examination score 10 to 24
  • 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 more.
  • Subjects who are only dementia of Alzheimer's type
  • Subjects who are right-handed
  • Subjects who are able to read and write
  • Both patient and legally responsible caregiver has provided informed consent
  • According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm

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 transient ischemic attack.
  • Subjects who have a History of DSM-IV Axis I disorders
  • Subjects who have neurologic problems on physical examination that cause memory disturbances
  • 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
  • Subjects 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YBand (YDT-201N)
transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 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 7 days a week for 12 weeks (total of 84 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
Measure Description
Time Frame
Change in cognitive function
Time Frame: from baseline to Week 6 and Week 12
Measured by ADAS-Cog 11
from baseline to Week 6 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in questionnaire
Time Frame: from baseline to Week 12
Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire
from baseline to Week 12
Change in cognitive function
Time Frame: from baseline to Week 6 and Week 12
Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), and Clinical Dementia Rating - Sum of Boxes(CDR-SOB)
from baseline to Week 6 and Week 12
Change in Korean version of Geriatric Depression Scale (K-GDS)
Time Frame: from baseline to Week 6 and Week 12
from baseline to Week 6 and Week 12
Change in activities of daily living
Time Frame: from baseline to Week 12
Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)
from baseline to Week 12
Change in behavioral symptoms
Time Frame: from baseline to Week 6 and Week 12
Measured by Neuropsychiatric Inventory
from baseline to Week 6 and Week 12
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in tDCS feedback
Time Frame: Week 2, 4, 6 and 12
Measured by tDCS feedback questionnaire
Week 2, 4, 6 and 12

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Collaborators

Ybrain Inc.

Investigators

  • Principal Investigator: Duk L. Na, MD, PhD, Samsung Medical Center

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

August 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 31, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2014-04-025

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.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Yband (YDT-201N)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe