Status:
RECRUITING
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
Lead Sponsor:
Ali Rezai
Conditions:
Alzheimer Disease
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due t...
Detailed Description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
Eligibility Criteria
Inclusion
- Males and non-pregnant females, aged 45-85 years
- Able and willing to give informed consent
- Must meet the clinical criteria for MCI due to Alzheimer's disease
- If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
- Able to communicate sensations during the LIFU procedure
Exclusion
- Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
- Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
- Participants with a history of seizure disorder.
- Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
- Participant does not speak English
- Participant is pregnant or planning to be pregnant
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05997030
Start Date
October 12 2023
End Date
September 30 2026
Last Update
November 24 2025
Active Locations (1)
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1
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, United States, 26505