Interleaved TMS-fMRI for Hippocampal Stimulation: Modeling Dose-Response Relationship in Amnestic Mild Cognitive Impairment
Completed · Phase 2 · Has a placebo group
Conditions studied: Mild Cognitive Impairment
In brief
Emerging evidence indicates that dysfunction of hippocampal synaptic plasticity, which precedes neuronal degeneration during the progression of Alzheimer's disease (AD), underlies the hallmark cognitive impairment. Although there are currently no effective disease modifying treatments for AD, recent preclinical studies in animal models of AD have suggested that repetitive transcranial magnetic stimulation (rTMS) promotes hippocampal synaptic plasticity and, ultimately, improves learning and memory abilities. Interleaved TBS-MRI is a paradigm, which allows the investigators to study human brain functionality with real-time MRI, to better understand modulations of brain activity in response to the non-invasive brain stimulation, TBS. The interleaved TBSfMRI paradigm can more accurately estimated the immediate brain activity compared to the offline TBS-MRI studies in which TBS is applied outside the MRI. With this interleaved TBS-MRI approach, the investigators will be able to measure immediate changes in targeted brain activity, such as hippocampus activation, following each TBS session. This approach has created the unprecedented potential enabling the investigators to model the dose-dependent effects of TBS more accurately on brain function.
Key facts
- Study ID
- NCT05515952
- Run by
- University of Arizona
- People needed
- 25
- Starts
- 2022-11-01
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2025-07-29
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 50-80 years
- MCI clinical criteria: (a) self- or informant-reported cognitive complaint; (b) preserved independence in functional abilities; and (c) absence of dementia.
- Objective cognitive impairment supported by the following measures of general cognitive function: (a) Mini-Mental State Exam (MMSE) 24-27 (inclusive); (b) Montreal Cognitive Assessment (MoCA) 18-26 (inclusive); or (c) Clinical Dementia Rating Scale score of 0.5.
- Right handed
- English speaking
- Able to attend daily intervention (Monday-Friday) for 4 days
- Not enrolled in another interventional study within 6 months prior to beginning this study
You may not qualify if…
- Contraindications to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI)
- Other neurological disorders (e.g. stroke, head injuries, or multiple sclerosis)
- Untreated depression
- Current cancer treatment or other medical problems that might independently affect cognitive function
- Clinical Dementia Rating Scale score more than 1.0
Where it is running
- Bioscience Research Laboratory — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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