Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain

Last updated: May 20, 2025
Sponsor: University of Utah
Overall Status: Completed

Phase

1/2

Condition

Chronic Pain

Fibromyalgia

Pain

Treatment

Sham stimulation with Diadem prototype

Verum stimulation with Diadem prototype

Clinical Study ID

NCT05674903
IRB_00162656
  • Ages 18-65
  • All Genders

Study Summary

This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-65, any gender

  2. Primary diagnosis of generalized chronic pain or widespread chronic pain.

  3. Moderate-to-severe chronic pain lasting at least 2 months

  4. Stated willingness to comply with all study procedures and avoid changes to currenttreatments (medications, physical therapy, cognitive behavioral therapy) for theduration of the study

  5. For females of reproductive potential: negative pregnancy test or use of highlyeffective contraception for at least 1 month prior to baseline; agreement to usesuch a method throughout the study

  6. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion

Exclusion Criteria:

  1. History of serious brain injury or other neurologic disorder

  2. Poorly managed general medical condition

  3. Pregnant or breast feeding

  4. Implanted device in the head or neck

  5. MRI intolerance or contraindication

  6. Brain stimulation (e.g., VNS, TMS) in the past month

  7. Lifetime history of a serious suicide attempt (Hooley et al., 2014)

  8. Clinically inappropriate for participation in the study as determined by the studyteam

Study Design

Total Participants: 47
Treatment Group(s): 2
Primary Treatment: Sham stimulation with Diadem prototype
Phase: 1/2
Study Start date:
July 10, 2023
Estimated Completion Date:
August 28, 2024

Connect with a study center

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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