Mild Cognitive Impairment Clinical Trial
Official title:
Noninvasive Cortical Stimulation to Improve Memory in Mild Cognitive Impairment
Verified date | May 2023 |
Source | Palo Alto Veterans Institute for Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 28, 2023 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 90 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Palo Alto Veterans Institute for Research | National Institute on Aging (NIA) |
United States,
Liao X, Li G, Wang A, Liu T, Feng S, Guo Z, Tang Q, Jin Y, Xing G, McClure MA, Chen H, He B, Liu H, Mu Q. Repetitive Transcranial Magnetic Stimulation as an Alternative Therapy for Cognitive Impairment in Alzheimer's Disease: A Meta-Analysis. J Alzheimers Dis. 2015;48(2):463-72. doi: 10.3233/JAD-150346. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in memory score, as measured by the California Verbal Learning Test-II (CVLT-II) | CVLT-II Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome) | Baseline, 1 week after completing the 20-session intervention | |
Secondary | Change from Baseline in memory score, as measured by the California Verbal Learning Test (CVLT-II) Trials 1-5 Total raw score | CVLT-II Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in depressive symptoms, as measured by the Geriatric Depression Scale (GDS) | GDS Total score (range: 0-15; higher values represent a worse outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in everyday functional outcomes, as measured by the Everyday Cognition (ECog) Questionnaire | ECog Scale Total score (range: 39-156; higher values represent a worse outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in global cognition, as measured by the Montreal Cognitive Assessment (MoCA) | MoCA Total score (range: 0 to 30; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in CVLT-II Semantic clustering | CVLT-II Semantic clustering (chance-adjusted) Trials 1-5 | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in CVLT-II Short-delay free recall | CVLT-II Short-delay free recall correct (range: 0-16; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in visuospatial memory, as measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) | BVMT-R Trials 1-3 Total raw score (range: 0-18; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in language function, as measured by Category Fluency (CF) | CF Total number of correct responses in 60 sec (higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in language function, as measured by 42-item Boston Naming Test (BNT) | BNT Total number of correct responses (range: 0-42; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in visuoconstructional function, as measured by the Rey-Osterrieth Complex Figure (ROCF), Copy score | ROCF Copy score (range: 0-36; higher values represent a better outcome) | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in speed of processing, as measured by Trail making | Trail making time to complete | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in attention, as measured by the Attentional Network Test (ANT) | ANT correct reaction time | Baseline, 6 months after completing the 20-session intervention | |
Secondary | Change from Baseline in brain functional connectivity | Change from Baseline in Functional connectivity metrics (derived from the pre- and the post-intervention functional magnetic resonance imaging (fMRI) scans rs-fMRI scans) will be computed with respect to: connectivity within the Default Mode Network (DMN), and connectivity between the DMN and the Central Executive Network (CEN). | Baseline, 1 week after completing the 20-session intervention | |
Secondary | Change from Baseline in levels of brain-derived neurotrophic factor (BDNF) | Plasma levels of BDNF will be measured from fasting blood samples that are collected at the first and last intervention sessions. | First Intervention session, to Last Intervention session (The average time frame from the first to the 20th and final session is 18 days) |
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