Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Sponsor

Ali Rezai (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05997030

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Device: low intensity focused ultrasound (LIFU)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neuromodulation Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation	Device: low intensity focused ultrasound (LIFU) Subjects will undergo undergo a single LIFU of the target brain region

Arm

Intervention/Treatment

Experimental: Neuromodulation

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

Device: low intensity focused ultrasound (LIFU)

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

Outcome Measures

Primary Outcome Measures

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.
Cognitive Change [baseline and 7 days after procedure]
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Secondary Outcome Measures

Imaging Changes [baseline, 7 and 30 days]
Changes in brain metabolism and connectivity using PET and fMRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ali Rezai

Investigators

Principal Investigator: Ali Rezai, WVU Rockefeller Neuroscience Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Rezai, Director RNI, West Virginia University

ClinicalTrials.gov Identifier:

NCT05997030

Other Study ID Numbers:

RNI_NMD_AD01

First Posted:

Aug 18, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Aug 18, 2023