Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Device: low intensity focused ultrasound (LIFU)

• Registration Number: NCT05997030
• Lead Sponsor: Ali Rezai

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 to Alzheimer's disease.

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

Study Timeline

• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-18
• Study Start: 2023-10-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuromodulation	low intensity focused ultrasound (LIFU)	Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

Primary Outcome Measures

Name	Time	Method
Cognitive Change	baseline and 7 days after procedure	Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Occurrence of Treatment Emergent Adverse Events	baseline and 7 and days after study procedure	Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

Secondary Outcome Measures

Name	Time	Method
Imaging Changes	baseline, 7 and 30 days	Changes in brain metabolism and connectivity using PET and fMRI

Trial Locations

Locations (1)

Rockefeller Neuroscience Institute at West Virginia University; 🇺🇸 Morgantown, West Virginia, United States