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Study of tDCS for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YBand (YDT-201N)
sham-YBand (YDT-201N)
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring transcranial direct current stimulation, tDCS, Mild Cognitive Impairment, MCI

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Incheon St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

YBand (YDT-201N)

sham-Yband (YDT-201N)

Arm Description

transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications)

sham-tDCS application 3 days a week for 12 weeks (total of 36 applications)

Outcomes

Primary Outcome Measures

Change in PET-CT images

Secondary Outcome Measures

Change in Cognitive function
Measured by SNSB
Change in Cognitive function
Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)
Change in activities of daily living
Measured by B-ADL
Change in Geriatric Depression Scale

Full Information

First Posted
December 16, 2014
Last Updated
August 7, 2018
Sponsor
Incheon St.Mary's Hospital
Collaborators
Ybrain Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02320890
Brief Title
Study of tDCS for Mild Cognitive Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital
Collaborators
Ybrain Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
transcranial direct current stimulation, tDCS, Mild Cognitive Impairment, MCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YBand (YDT-201N)
Arm Type
Experimental
Arm Description
transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications)
Arm Title
sham-Yband (YDT-201N)
Arm Type
Sham Comparator
Arm Description
sham-tDCS application 3 days a week for 12 weeks (total of 36 applications)
Intervention Type
Device
Intervention Name(s)
YBand (YDT-201N)
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
sham-YBand (YDT-201N)
Intervention Description
transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Primary Outcome Measure Information:
Title
Change in PET-CT images
Time Frame
from baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Cognitive function
Description
Measured by SNSB
Time Frame
from baseline to Week 12
Title
Change in Cognitive function
Description
Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)
Time Frame
from baseline to Week 12
Title
Change in activities of daily living
Description
Measured by B-ADL
Time Frame
from baseline to Week 12
Title
Change in Geriatric Depression Scale
Time Frame
from baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-An Chung, M.D., Ph.D.
Organizational Affiliation
Professor, Department of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon St.Mary's Hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of

12. IPD Sharing Statement

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Study of tDCS for Mild Cognitive Impairment

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