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

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Yband (YDT-201N)

sham-Yband (YDT-201N)

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, AD, tDCS, transcranial direct current stimulation

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Samsung Medical CenterRecruiting

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 cognitive function

Measured by ADAS-Cog 11

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 cognitive function

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)

Change in Korean version of Geriatric Depression Scale (K-GDS)

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 behavioral symptoms

Measured by Neuropsychiatric Inventory

Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)

Change in tDCS feedback

Measured by tDCS feedback questionnaire

Full Information

NCT ID

NCT02227953

First Posted

August 26, 2014

Last Updated

August 31, 2014

Sponsor

Samsung Medical Center

Collaborators

Ybrain Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02227953

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 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

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 Alzheimer's disease

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's Disease, AD, 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

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 cognitive function

Description

Measured by ADAS-Cog 11

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 cognitive function

Description

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)

Time Frame

from baseline to Week 6 and 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 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 behavioral symptoms

Description

Measured by Neuropsychiatric Inventory

Time Frame

from baseline to Week 6 and 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Duk-Lyul Na, MD, PhD

Phone

+82-2-3410-3594

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Duk L Na, MD, PhD

Phone

+82-2-3410-2594

dukna@naver.com

12. IPD Sharing Statement

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

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