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CompletedNCT02320890Updated Aug 8, 2018

Study of tDCS for Mild Cognitive Impairment

An interventional study of YBand (YDT-201N) and sham-YBand (YDT-201N) in Mild Cognitive Impairment, sponsored by Incheon St.Mary's Hospital. Completed at 1 site in South Korea. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Incheon St.Mary's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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)

Read the detailed description

Twenty-four 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 the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • transcranial direct current stimulation
  • tDCS
  • Mild Cognitive Impairment
  • MCI
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's enrollment of 16 is below the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Incheon St.Mary's Hospital is the lead sponsor of 20 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

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 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    YBand (YDT-201N)

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

    Device: YBand (YDT-201N)

  • Sham comparator
    sham-Yband (YDT-201N)

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

    Device: sham-YBand (YDT-201N)

Interventions

  • DeviceYBand (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)

  • Devicesham-YBand (YDT-201N)

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

06

What researchers measure

Primary outcomes

  1. Change in PET-CT images

    Time frame: from baseline to Week 12

Secondary outcomes

  1. Change in Cognitive function

    Measured by SNSB

    Time frame: from baseline to Week 12

  2. Change in Cognitive function

    Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)

    Time frame: from baseline to Week 12

  3. Change in activities of daily living

    Measured by B-ADL

    Time frame: from baseline to Week 12

  4. Change in Geriatric Depression Scale

    Time frame: from baseline to Week 12

07

Study locations

1 site
  • Incheon St.Mary's Hospital
    Incheon, 403-720, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2014
First posted
Dec 19, 2014
Start
Dec 2014
Primary completionActual
Oct 2015
CompletionActual
Oct 2015
Last update
Aug 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02320890
Lead sponsor
Incheon St.Mary's Hospital
Collaborators
Ybrain Inc.
Responsible party
Yong An Chung (Professor of Radiology, Catholic University of Korea, Incheon St.Mary's Hospital) — Principal investigator
First posted
Dec 19, 2014
Start date
Dec 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Aug 8, 2018

Study contacts

Yong-An Chung, M.D., Ph.D.
principal investigator · Professor, Department of Radiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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