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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).
Full 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.
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Inclusion and exclusion criteria
Inclusion Criteria
Must speak English fluently
Diagnosis of MCI as defined by:
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
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
Psychiatric disorders
Active symptoms of depression, anxiety, mania, psychosis, or substance use (except caffeine and nicotine) within the past year
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
Primary purpose
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25 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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