Noninvasive Brain Stimulation for Mild Cognitive Impairment
United States69 participantsStarted 2018-06-15
Plain-language summary
The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3: Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase (20 rTMS sessions) and a 6-month follow-up phase.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Both Veterans and Non-Veterans may enroll if they meet the following criteria \*\*
Inclusion Criteria:
* Diagnosed with amnestic Mild Cognitive Impairment (aMCI);
* Stable medications (including any dementia-related meds) for at least 4 weeks prior to Baseline;
* Geriatric Depression Scale score less than 6;
* Ability to obtain a motor threshold, determined during the screening process;
* Study partner available; living situation enables attendance at clinic visits;
* Visual and auditory acuity adequate for neuropsychological testing;
* Good general health with no diseases expected to interfere with the study;
* Participant is not pregnant or of childbearing potential (i.e. women must be 2 years post-menopausal or surgically sterile);
* Modified Hachinski Ischemic score less than or equal to 4;
* Agree to DNA extraction for single nucleotide polymorphism (SNP) genotyping;
* Able to understand study procedures and comply with them for the entire length of the study.
Exclusion Criteria:
* Prior exposure to rTMS within the past 12 months;
* Magnetic field safety concern such as a cardiac pacemaker, cochlear implant, implanted device in the brain (deep brain stimulation), or metal fragments or foreign objects in the eyes, skin or body;
* Any significant neurological disease other than suspected incipient Alzheimer's disease;
* Unstable cardiac disease or recent (\< 3 months previous) myocardial infarction. Any significant systemic illness or unstable medical condition that …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Number of Words Correctly Recalled, List Learning, California Verbal Learning Test-II, Assessed 1 Week After Intervention and Adjusted for Baseline Performance
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.