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OpenTrials
Completed

NCT Number: NCT02320890

Study of tDCS for Mild Cognitive Impairment

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)

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Incheon St.Mary's Hospital

Incheon, 403-720, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

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)

sham-YBand (YDT-201N)

Device

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

Primary outcomes

  1. Change in PET-CT images

    Time frame: from baseline to Week 12

Secondary outcomes

  1. Change in Cognitive function

    Time frame: from baseline to Week 12

    Measured by SNSB

  2. Change in Cognitive function

    Time frame: from baseline to Week 12

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

  3. Change in activities of daily living

    Time frame: from baseline to Week 12

    Measured by B-ADL

  4. Change in Geriatric Depression Scale

    Time frame: from baseline to Week 12

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Collaborators

  • Ybrain Inc.

Registry information

Official study title

A Study for the Short- and Long-term Improvement of Cognitive Function (Evaluated by PET-CT and SNSB) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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