Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

NCT05997030 | Recruiting DMC FDA Device

• 1 other identifier: RNI_NMD_AD01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment Emergent Adverse Events

  Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

  baseline and 7 and days after study procedure

• Cognitive Change

  Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  baseline and 7 days after procedure

Secondary Outcomes (1)

• Imaging Changes

  baseline, 7 and 30 days

Study Arms (1)

Neuromodulation

EXPERIMENTAL

Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

Device: low intensity focused ultrasound (LIFU)

Interventions

low intensity focused ultrasound (LIFU) DEVICE

Subjects will undergo undergo a single LIFU of the target brain region

Neuromodulation

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Rezai: lead

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ali Rezai, MD

  WVU Rockefeller Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Haut, PhD

CONTACT

3042936276; mhaut@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director RNI

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 18, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)