Phase
Condition
Mild Cognitive Impairment
Alzheimer's Disease
Dementia
Treatment
iTBS rTMS
Clinical Study ID
Ages 55-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Must speak English fluently
Diagnosis of MCI as defined by:
Clinical diagnosis by a neurologist
Neuropsychological testing support of MCI
Meet criteria for MCI
Subjective cognitive decline reported by participant and/or an informant
Objective memory impairment in one or more cognitive domains for age
Essentially preserved general cognitive function
Largely intact functional activities
Does not meet criteria for dementia as judged by a clinician
Eligible for transcranial magnetic stimulation (TMS) based on safety criteria
Clinical Dementia Rating=0.5
Geriatric Depression Scale score less than 6
Medically stable and in good general health
Not pregnant, lactating, or of childbearing potential
Stable medication regimen for at least 4 weeks prior to baseline visit
Adequate visual and auditory abilities to complete neuropsychological testing
Ability to provide informed consent
Have a care partner who is available to accompany the participant to study visits for the duration of the protocol.
Exclusion Criteria
Inability to communicate in the English language
Meet criteria for dementia
Contraindications to TMS or MRI, including patients who have
conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or jewelry)
active or inactive implants, including deep brain stimulators, cochlear implants, vagus nerve stimulators or implanted device leads
Any true positive findings on the TMS safety screening form
Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within the past 12 months
History of epilepsy or seizures
Medical conditions that increase risk of seizures
History of traumatic brain injury
History of intracranial mass or lesion
History of stroke, including hemorrhagic stroke and ischemic stroke
Psychiatric disorders
Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform disorder), any history
Primary mood disorder (major depressive disorder, bipolar disorder) within the past 12 months
Substance use disorder (except caffeine and nicotine) within the past 12 months
Active symptoms of depression, anxiety, mania, psychosis, or substance use (except caffeine and nicotine) within the past year
Active symptoms of depression will be identified based on geriatric depression scale ≥ 6
Other active symptoms of psychiatric conditions to be determined by study investigators
Sleep disorders that are considered clinically significant and not sufficiently treated by the investigative team, including untreated obstructive sleep apnea (apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior disorder, untreated/suboptimally treated restless legs syndrome
Pregnancy or suspected pregnancy
Participation in another concurrent interventional clinical trial
Any unstable medical condition
Inability to provide informed consent
Inability to adhere to the protocol
Study Design
Study Description
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
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