Low-Intensity Focused Ultrasound and the Complex Patient

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT06297200
Status
Recruiting

Conditions

  • Anxiety Disorder
  • Chronic Pain
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Intensity Focused Ultrasound — DEVICE
    A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
  • Low-Intensity Focused Ultrasound - sham — DEVICE
    A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Study Details

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Key Dates

Start date
Dec 4, 2024
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Pain, Craving, and Anxiety measures
    Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events via a neurological examination [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fralin Biomedical Research Institute at VTCRoanokeVirginia24016
Jessica Florig, MPH
540-526-2261
Wynn Legon, PhD (PRINCIPAL_INVESTIGATOR)

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