A Pilot Study of tDCS for Mild Cognitive Impairment

NCT02227966 | Unknown

• 1 other identifier: SMC 2014-04-026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; MCI; tDCS; transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

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

  from baseline to Week 6 and Week 12

Secondary Outcomes (7)

• Change in questionnaire

  from baseline to Week 12

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

  from baseline to Week 12

• Change in tDCS feedback

  Week 2, 4, 6 and 12

• Change in activities of daily living

  from baseline to Week 12

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

  from baseline to Week 6 and Week 12

Study Arms (2)

YBand (YDT-201N)

EXPERIMENTAL

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

Device: Yband (YDT-201N)

sham-YBand (YDT-201N)

SHAM COMPARATOR

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

Device: Sham-Yband (YDT-201N)

Interventions

Yband (YDT-201N) 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)

YBand (YDT-201N)

Sham-Yband (YDT-201N) DEVICE

tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex

sham-YBand (YDT-201N)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ybrain Inc.: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Duk L. Na, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duk-Lyul Na, MD, PhD

CONTACT

+82-2-3410-3594; dukna@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Sungkyunkwan University School of Medicine

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-08

Locations

KR (1)