Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Ali Rezai

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Device: low intensity focused ultrasound (LIFU)

Study type: Interventional

Funder types: Other

Identifiers

NCT05997030

RNI_NMD_AD01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Neuromodulation

Experimental group

Description:

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

Treatment:

Device: low intensity focused ultrasound (LIFU)