Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-007478
Sponsor Protocol Number: 16-007478
About this study
The purpose of this study is to investigate whether giving transcranial direct current stimulation (tDCS) treatment using an investigational device called the Soterix tES Device (tDCS device) on the right side of the brain can improve performance on cognitive tests. Investigational means that the tDCS device is not approved by the U.S. Food and Drug Administration (FDA) for the use in this study.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or female outpatients with confirmed MCI diagnosis or who are cognitively unimpaired (CU) as verified by the Montreal Cognitive Assessment (MoCA) scoring ≥26.
- Age 55-85.
- Right handed (tested using the Edinburgh handedness inventory [19]).
- Total PHQ-8 of ≤ 9 which signifies no moderate or severe depression [20].
- All participants and/or caregivers must be able to provide informed consent.
Exclusion Criteria:
- 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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Yonas Geda, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available