Noninvasive Brain Stimulation for Mild Cognitive Impairment
Mild Cognitive Impairment, Mild Neurocognitive Disorder, Cognitive Decline
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, tms, rtms, transcranial magnetic stimulation, noninvasive brain stimulation, non-pharmacological
Eligibility Criteria
- 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 could lead to difficulty with protocol adherence;
- History of epilepsy or repetitive seizures, as determined by patient report or chart review;
History of a medical condition or current use/abuse of medications and substances that increase the risk of a seizure, specifically:
- Traumatic brain injury within 2 months that would increase the risk for seizure;
- Unable to safely withdraw, at least 4 weeks prior to Baseline, from medications that substantially increase the risk of having seizures (for example: theophylline, clozapine, and methylphenidate).
- Current or past history of a mass lesion, cerebral infarct, or other noncognitive active neurological disease that would increase the risk for seizure.
- Stimulant abuse within the previous 90 days. Cocaine and abuse of amphetamine and methylphenidate are associated with an increased risk of seizures;
- Major depression or bipolar disorder (DSM-IV) within the past 1 year, or psychotic features within the last 3 months that could lead to difficulty with protocol adherence;
- Taking sedative hypnotics or medications with anti-cholinergic properties and unable to withdraw at least 4 weeks prior to Baseline;
- Current alcohol or substance abuse (not including caffeine or nicotine) within the past 1 year, as determined by chart review, participant or study partner report, or greater than "moderate" alcohol use defined by the Quantity-Frequency-Variability Index (Cahalan, Cisin, & Crossley, 1969);
- Any contraindications for magnetic resonance imaging (MRI) studies, e.g. severe claustrophobia, weight above 350 lb maximum allowed by MRI scanner, pregnancy;
- Participation in another concurrent clinical trial;
- Inability or unwillingness of individual or legal representative to give written informed consent.
Sites / Locations
- VA Palo Alto Health Care System
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Active rTMS (Bilateral DLPFC)
Active rTMS (Bilateral LPC)
Placebo rTMS (Inactive)
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.