Clinical trial NCT02320890: Study of tDCS for Mild Cognitive Impairment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: transcranial direct current stimulation
tDCS
Mild Cognitive Impairment
MCI
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2014-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in PET-CT images
timeFrame: from baseline to Week 12
Secondary outcomes:
measure: Change in Cognitive function
timeFrame: from baseline to Week 12
measure: Change in Cognitive function
timeFrame: from baseline to Week 12
measure: Change in activities of daily living
timeFrame: from baseline to Week 12
measure: Change in Geriatric Depression Scale
timeFrame: from baseline to Week 12
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital
Study officials:
affiliation: Professor, Department of Radiology
name: Yong-An Chung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: