Status:
COMPLETED
Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Center of Neuromodulation for Rehabilitation
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
65-85 years
Phase:
NA
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 sti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04503096
Start Date
April 12 2021
End Date
July 27 2022
Last Update
September 7 2023
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425