A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Maria I. Lapid, M.D.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Clinician Referrals
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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 (rTMS) in adults with mild cognitive impairment (MCI), and to test whether iTBS rTMS treatments can improve memory in mild cognitive impairment (MCI).
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 with Mild Cognitive Impairment (MCI), pilot test the study protocol to assess study design, and collect pilot data on the effect of stimulations over 3 different brain regions (left dorsolateral prefrontal cortex (DLPFC), lateral parietal cortex (LPC), vertex) on working memory, new-learning and executive function in MCI. Neuropsychological and sleep measures, functional brain magnetic resonance imaging (fMRI), high density EEG and questionnaires will be performed at 5 timepoints - baseline, post-treatment after first period of 10 daily iTBS rTMS sessions, post-washout period of 4 weeks, post-treatment after cross-over to second period of 10 daily iTBS rTMS sessions, and 4 weeks follow-up post-treatment.
Investigators
Maria I. Lapid, M.D.
Principal Investigator
Mayo Clinic
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
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
Outcomes
Primary Outcomes
Clinician Referrals
Time Frame: 16 weeks
Total number of participants referred to the study by clinicians
Participant enrollment
Time Frame: 16 weeks
Total number of participants enrolled in the study
Treatment adherence
Time Frame: 16 weeks
Total number of participants to comply with all study procedures as identified in the protocol