Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neuromodulation

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

Group Type EXPERIMENTAL

low intensity focused ultrasound (LIFU)

Intervention Type DEVICE

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

Interventions

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low intensity focused ultrasound (LIFU)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No