iTBS rTMS in Mild Cognitive Impairment

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Transcranial Magnetic Stimulation Read More

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 or use of medications 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
  • Medications associated with seizures (Examples: Analgesics - Opioids (e.g., meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab; Antimicrobials - Carbapenems (e.g., imipenem), Cephalosporins (fourth generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins; Hypoglycemic agents; Immunosuppressants - Azathioprine, Cyclosporine, Mycophenolate, Tacrolimus; Psychiatric medications - Antipsychotics, Atomoxetine, Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs - Aminophylline, Theophylline; Stimulants - Amphetamines, Methylphenidate; Sympathomimetics and decongestants - Anorexiants (e.g., diethylpropion, phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)

• 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