NCT05997030 · Ali Rezai
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
What this study is about
This study is a forward-looking, single-center, single-treatment group$1 early feasibility study, to establish safety and how well patients handle the treatment of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Morgantown, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations