CompletedNot Applicable

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 range55 Years – 90 Years

SexALL

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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 …

What they're measuring

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.

Trial details

NCT IDNCT03331796

SponsorPalo Alto Veterans Institute for Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-19

Results submitted2024-03-28