Clinical trial NCT02227953: A Pilot Study of tDCS for Mild to Moderate Alzhemier's Disease
Official title: A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 11) After Transcranial Direct Current Stimulation in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
AD
tDCS
transcranial direct current stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ybrain Inc.
First posted: 2014-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Alzheimer's disease

Detailed description: Twenty 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 home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.

Eligibility criteria: Inclusion Criteria:

* Subjects who have Korean version of Mini Mental Status Examination score 10 to 24
* 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 more.
* Subjects who are only dementia of Alzheimer's type
* Subjects who are right-handed
* Subjects who are able to read and write
* Both patient and legally responsible caregiver has 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

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 transient ischemic attack.
* Subjects who have a History of DSM-IV Axis I disorders
* Subjects who have neurologic problems on physical examination that cause memory disturbances
* 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)

Primary outcomes:
measure: Change in cognitive function
timeFrame: from baseline to Week 6 and Week 12
Secondary outcomes:
measure: Change in questionnaire
timeFrame: from baseline to Week 12
measure: Change in cognitive function
timeFrame: from baseline to Week 6 and Week 12
measure: Change in Korean version of Geriatric Depression Scale (K-GDS)
timeFrame: from baseline to Week 6 and Week 12
measure: Change in activities of daily living
timeFrame: from baseline to Week 12
measure: Change in behavioral symptoms
timeFrame: from baseline to Week 6 and Week 12
measure: Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
timeFrame: from baseline to Week 12
measure: Change in tDCS feedback
timeFrame: Week 2, 4, 6 and 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk L. Na, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: