NCT02320890

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

December 16, 2014

Last Update Submit

August 7, 2018

Conditions

Mild Cognitive Impairment

Keywords

transcranial direct current stimulationtDCSMild Cognitive ImpairmentMCI

Outcome Measures

Primary Outcomes (1)

  • Change in PET-CT images

    from baseline to Week 12

Secondary Outcomes (4)

  • Change in Cognitive function

    from baseline to Week 12

  • Change in Cognitive function

    from baseline to Week 12

  • Change in activities of daily living

    from baseline to Week 12

  • Change in Geriatric Depression Scale

    from baseline to Week 12

Study Arms (2)

YBand (YDT-201N)

EXPERIMENTAL

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

Device: YBand (YDT-201N)

sham-Yband (YDT-201N)

SHAM COMPARATOR

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

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

sham-Yband (YDT-201N)

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St.Mary's Hospital

Incheon, 403-720, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yong-An Chung, M.D., Ph.D.

    Professor, Department of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology, Catholic University of Korea

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

KR(1)