Study of tDCS for Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320890
• Other study ID #: OC14OISI0045
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: August 2018
• Source: Incheon St.Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Incheon St.Mary's Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital	Ybrain Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PET-CT images		from baseline to Week 12
Secondary	Change in Cognitive function	Measured by SNSB	from baseline to Week 12
Secondary	Change in Cognitive function	Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)	from baseline to Week 12
Secondary	Change in activities of daily living	Measured by B-ADL	from baseline to Week 12
Secondary	Change in Geriatric Depression Scale		from baseline to Week 12