NCT05997030Recruiting
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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 to Alzheimer's disease.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 4 Aug 2023
- Start date
- 12 Oct 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Ali Rezai
- Diseases
- Alzheimer disease
- NCT number
- NCT05997030
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 12 Oct 2023 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Participant does not speak English
- Participant is pregnant or planning to be pregnant
Who the study is looking for
- 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
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rockefeller Neuroscience Institute at West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.