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

NCT ID: NCT02227953

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

YBand (YDT-201N)

transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications)

Group Type: EXPERIMENTAL

Yband (YDT-201N)

Intervention Type: DEVICE

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-Yband (YDT-201N)

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

Group Type: SHAM_COMPARATOR

sham-Yband (YDT-201N)

Intervention Type: DEVICE

transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Interventions

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)

Intervention Type: DEVICE

sham-Yband (YDT-201N)

transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ybrain Inc.

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Duk Lyul Na

Professor of Neurology, Sungkyunkwan University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duk L. Na, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Duk-Lyul Na, MD, PhD

Role: CONTACT

dukna@naver.com

+82-2-3410-3594

Facility Contacts

Duk L Na, MD, PhD

Role: primary

dukna@naver.com

+82-2-3410-2594

Other Identifiers

SMC 2014-04-025

Identifier Type: -

Identifier Source: org_study_id