A Pilot Study of tDCS for Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 13) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02227966
• Other study ID #: SMC 2014-04-026
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2014
• Last updated: August 31, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: Samsung Medical Center
• Contact: Duk-Lyul Na, MD, PhD
• Phone: +82-2-3410-3594
• Email: dukna[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 Mild Cognitive Impairment (MCI)

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). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects who have a subjective memory impairment

• Subjects who have Korean version of Mini Mental Status Examination score 24 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 with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem

• Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower

• Subjects who are right-handed

• Subjects who are able to read and write

• Both subject and legally responsible caregiver have 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 neurologic problems on physical examination that cause 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

• Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• Yband (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)
• Sham-Yband (YDT-201N)
tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ybrain Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)		from baseline to Week 6 and Week 12	No
Secondary	Change in questionnaire	Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire	from baseline to Week 12	No
Secondary	Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)		from baseline to Week 12	No
Secondary	Change in tDCS feedback	Measured by tDCS feedback questionnaire	Week 2, 4, 6 and 12	No
Secondary	Change in activities of daily living	Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)	from baseline to Week 12	No
Secondary	Change in Korean version of Geriatric Depression Scale (K-GDS)		from baseline to Week 6 and Week 12	No
Secondary	Change in cognitive function	Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), Clinical Dementia Rating - Sum of Boxes(CDR-SOB), Free and Cued Selective Reminding Test (FCSRT), Cambridge Neuropsychological Test Automated Battery (CANTAB battery), COWAT (Controlled Oral Word Association Test), Stroop test, Digit symbol coding, and Trail making test (TMT)	from baseline to Week 6 and Week 12	No
Secondary	Change in Multifactorial Memory Questionnaire (MMQ)		from baseline to Week 6 and Week 12	No