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Focused Ultrasound for the Complex Patient

NCT06453109 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-11-20

No results posted yet for this study

Summary

The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are:

* the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain
* the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving

Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.

Conditions

Interventions

DEVICE

low intensity focused ultrasound (LIFU)

Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Washington D.C. Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Mary R Lee, MD · Washington D.C. Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453109 on ClinicalTrials.gov