Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
Completed · Not applicable · Has a placebo group
Conditions studied: Mild Cognitive Impairment, Cognitive Impairment, Neurocognitive Dysfunction
In brief
This study evaluates the application of non-invasive brain stimulation in the treatment of Mild Cognitive Impairment (MCI) in adults aged 55-85. Half of the participants will receive transcranial direct current stimulation (tDCS), while the other half will receive sham (like placebo) stimulation.
Key facts
- Study ID
- NCT03521089
- Run by
- Mayo Clinic
- People needed
- 16
- Starts
- 2018-02-20
- Expected to finish
- 2019-05-31
- Last updated by the study team
- 2020-03-25
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female outpatients with confirmed MCI diagnosis
- Age 55-85
- Right handed (tested using the Edinburgh handedness inventory)
- Total PHQ-8 of ≤ 16 which signifies no severe depression
- All participants and/or caregivers must be able to provide informed consent
You may not qualify if…
- Neurodegenerative disease (e.g. Parkinson's, Huntington's, Multiple Sclerosis) other than MCI
- Previous brain lesion
- Intracranial abnormality such as prior stroke
- History of seizure disorder or epilepsy
- A "true" positive response, after patient clarification, to any question on the modified TMS/tDCS Adult Safety Screen questionnaire that would impact patient safety
- Any history of brain stimulation treatment (e.g., electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagal nerve therapy (VNS), deep brain stimulation (DBS))
- Use of any investigational drug within 4 weeks
- Cardiac pacemakers, implanted medication pumps, intracardiac lines; acute or unstable cardiac disease; intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (exception: mouth/dental work) that cannot be safely removed
- Known or suspected pregnancy (extremely unlikely as the age range for this study is 55-85 years)
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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