Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Launched by ALI REZAI · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a new technique called Low-Intensity Focused Ultrasound (LIFU) to see if it can safely help people with mild cognitive impairment (MCI) caused by Alzheimer's disease. The goal is to find out if this method is safe and comfortable for patients. The study is currently looking for participants aged 45 to 85 years who have been diagnosed with MCI due to Alzheimer's and can communicate their feelings during the procedure.

To be eligible, participants must be men or non-pregnant women who are able to give their consent and are stable on certain medications if they are taking them. However, some people may not qualify, such as those with certain medical implants or conditions that prevent them from undergoing MR imaging, which is part of the process. If you decide to take part in this study, you can expect to receive the LIFU treatment and share your experiences. Your feedback will help researchers understand how well this approach works for people with Alzheimer's-related cognitive issues.

Gender

ALL

Eligibility criteria

• 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