Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT05327257
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT05327257
Study Brief:
Protocol Section:
NCT05327257