Clinical trial NCT04503096: Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI
Official title: High-dose Accelerated Repetitive Transcranial Magnetic Stimulation to Cognitive Control Neurocircuitry in Mild Cognitive Impairment: A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Center of Neuromodulation for Rehabilitation
First posted: 2020-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI). Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In studies of TMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, the current study is testing whether TMS is safe, feasible and effective in improving cognition in individuals with MCI.


Eligibility criteria: Inclusion Criteria:

* Age 60-85
* English as a first/primary language
* Has been diagnosed with MCI by a healthcare provider within the past two years per National Institute on Aging - Alzheimer's Association (NIA-AA) criteria: (1) Concern regarding cognitive decline reported by patient, informant, or clinician, (2) Objective evidence of impairment for age in 1+ cognitive domains, typically memory, (3) Preserved independent function, (4) no dementia.
* Has met actuarial neuropsychological criteria for amnestic MCI: (1) ≥2 impaired scores (i.e. ≤16th %ile) within one cognitive domain, or (2) ≥1 impaired scores (i.e. ≤16th %ile) in ≥3 cognitive domains, using demographically-corrected normative data. (1) and (2) must include the Memory domain.
* The primary suspected etiology of amnestic MCI must be neurodegenerative, with competing differential diagnoses (e.g. psychiatric disorder, movement disorder, reversible causes, substance use) ruled out as the primary etiology/ies following a clinical evaluation by a healthcare provider.
* Ability to provide independent informed consent, consistent with the MCI diagnostic criterion of preserved independent function.

Exclusion Criteria:

* Dementia diagnosis per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or NIA-AA criteria.
* Daily/weekly use of anticholinergics, neuroleptics, sedatives, or bupropion. Stimulant use may be allowed pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen of four weeks prior to enrollment.
* History of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, severe mental illness (e.g. bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder, or other neurologic disease (e.g. severe brain injury, seizures).
* MRI and TMS contraindications (e.g., implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no quantifiable motor threshold, active substance use disorder, bipolar disorder).
* Is enrolled in a clinical trial and/or has received an investigational medication within the last 30 days.

Primary outcomes:
measure: Number of Participants With Clinically Significant Structural Brain Change on T1- and T2-weighted Magnetic Resonance Imaging (MRI)
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
measure: Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
measure: Change in the Review of Systems Criteria Compared to Baseline
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
measure: Patient Perception of Treatment Acceptability
timeFrame: Administered at post-treatment
measure: Retention Rate
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Secondary outcomes:
measure: Change From Baseline Depression, as Measured by the Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
measure: Change From Baseline Depression, as Measured by the Geriatric Depression Scale (GDS)
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
measure: Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery
timeFrame: Baseline prior to treatment and at follow-up within 1 week post-treatment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Andreana Benitez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Lisa McTeague, PhD
role: PRINCIPAL_INVESTIGATOR
References: