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A Pilot Study of tDCS for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Yband (YDT-201N)
Sham-Yband (YDT-201N)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, MCI, tDCS, transcranial Direct Current Stimulation

Eligibility Criteria

65 Years - 80 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 24 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 with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem
  • Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
  • Subjects who are right-handed
  • Subjects who are able to read and write
  • Both subject and legally responsible caregiver have 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 neurologic problems on physical examination that cause 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
  • Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Sites / Locations

  • Samsung Medical Center

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 7 days a week for 12 weeks (total of 84 applications)

sham-tDCS application 7 days a week for 12 weeks (total of 84 applications)

Outcomes

Primary Outcome Measures

Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)

Secondary Outcome Measures

Change in questionnaire
Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Change in tDCS feedback
Measured by tDCS feedback questionnaire
Change in activities of daily living
Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)
Change in Korean version of Geriatric Depression Scale (K-GDS)
Change in cognitive function
Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), Clinical Dementia Rating - Sum of Boxes(CDR-SOB), Free and Cued Selective Reminding Test (FCSRT), Cambridge Neuropsychological Test Automated Battery (CANTAB battery), COWAT (Controlled Oral Word Association Test), Stroop test, Digit symbol coding, and Trail making test (TMT)
Change in Multifactorial Memory Questionnaire (MMQ)

Full Information

First Posted
August 26, 2014
Last Updated
August 31, 2014
Sponsor
Samsung Medical Center
Collaborators
Ybrain Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02227966
Brief Title
A Pilot Study of tDCS for Mild Cognitive Impairment
Official Title
A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 13) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Ybrain Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this preliminary 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 patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, MCI, tDCS, transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YBand (YDT-201N)
Arm Type
Experimental
Arm Description
transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications)
Arm Title
sham-YBand (YDT-201N)
Arm Type
Sham Comparator
Arm Description
sham-tDCS application 7 days a week for 12 weeks (total of 84 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
tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)
Time Frame
from baseline to Week 6 and Week 12
Secondary Outcome Measure Information:
Title
Change in questionnaire
Description
Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire
Time Frame
from baseline to Week 12
Title
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Time Frame
from baseline to Week 12
Title
Change in tDCS feedback
Description
Measured by tDCS feedback questionnaire
Time Frame
Week 2, 4, 6 and 12
Title
Change in activities of daily living
Description
Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)
Time Frame
from baseline to Week 12
Title
Change in Korean version of Geriatric Depression Scale (K-GDS)
Time Frame
from baseline to Week 6 and Week 12
Title
Change in cognitive function
Description
Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), Clinical Dementia Rating - Sum of Boxes(CDR-SOB), Free and Cued Selective Reminding Test (FCSRT), Cambridge Neuropsychological Test Automated Battery (CANTAB battery), COWAT (Controlled Oral Word Association Test), Stroop test, Digit symbol coding, and Trail making test (TMT)
Time Frame
from baseline to Week 6 and Week 12
Title
Change in Multifactorial Memory Questionnaire (MMQ)
Time Frame
from baseline to Week 6 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 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 24 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 with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower Subjects who are right-handed Subjects who are able to read and write Both subject and legally responsible caregiver have 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 neurologic problems on physical examination that cause 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 Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duk-Lyul Na, MD, PhD
Phone
+82-2-3410-3594
Email
dukna@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk L. Na, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duk L Na, MD, PhD
Phone
+82-2-3410-2594
Email
dukna@naver.com

12. IPD Sharing Statement

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A Pilot Study of tDCS for Mild Cognitive Impairment

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