common.study.topics.clinical

Neuromodulation in Patients with Opioid Use Disorder

common.study.values.description

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD)

The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the ExablateAR Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) by assessing its safety and tolerability in subjects with OUD.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Device - Exablate Model 4000 Type 2.0/2.1

There are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.

participant.views.study.view.additional

participant.views.study.view.scientific-title

A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD)

common.study.values.clinical-trial-id

NCT04197921

participant.views.study.view.id

aM8LQe