Status:
COMPLETED
Noninvasive Brain Stimulation for Mild Cognitive Impairment
Lead Sponsor:
Palo Alto Veterans Institute for Research
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Mild Neurocognitive Disorder
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief 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 ...
Detailed Description
This study aims to test the efficacy of a non-pharmacological treatment for MCI that involves noninvasive brain stimulation (NIBS). Early studies in Alzheimer's disease (AD) dementia patients have fou...
Eligibility Criteria
Inclusion
- Both Veterans and Non-Veterans may enroll if they meet the following 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
- 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.
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03331796
Start Date
June 15 2018
End Date
March 28 2023
Last Update
September 3 2025
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304