Status:
ACTIVE_NOT_RECRUITING
iTBS rTMS in Mild Cognitive Impairment
Lead Sponsor:
Maria I. Lapid, M.D.
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief Summary
The purposes of this research are to test whether it is feasible to administer a treatment protocol called intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTM...
Detailed Description
To test the feasibility of conducting a 10-day Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) protocol twice using a cross-over design in individuals w...
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
Exclusion
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05327257
Start Date
August 11 2022
End Date
December 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905