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Completed

NCT Number: NCT05674903

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

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.

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Key information

Conditions

Chronic Pain Chronic Pain Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Widespread Chronic Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65, any gender
  • Primary diagnosis of generalized chronic pain or widespread chronic pain.
  • Moderate-to-severe chronic pain lasting at least 2 months
  • Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
  • For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
  • Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion criteria

  • History of serious brain injury or other neurologic disorder
  • Poorly managed general medical condition
  • Pregnant or breast feeding
  • Implanted device in the head or neck
  • MRI intolerance or contraindication
  • Brain stimulation (e.g., VNS, TMS) in the past month
  • Lifetime history of a serious suicide attempt (Hooley et al., 2014)
  • Clinically inappropriate for participation in the study as determined by the study team

Treatment and study plan

Verum stimulation with Diadem prototype

Device

Diadem prototype device delivers focused low-intensity ultrasound stimulation

Sham stimulation with Diadem prototype

Device

Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation

Primary outcomes

  1. Target engagement: brain activation

    Time frame: 1 day At MRI study visit

    MRI quantification of blood oxygenation level dependent (BOLD) activation.

  2. Target engagement: brain connectivity

    Time frame: 1 day At MRI study visit

    Pearson's correlation of BOLD signals between the stimulated target and connected regions.

  3. Pain intensity: momentary change

    Time frame: 1 day At stimulation visit

    Computerized Visual Analogue Scale. The scale is measured using a continuous slider. At its left boundary, the slider indicates no pain (score 0). At its right boundary, the slider indicates worst pain imaginable (score 100). A lower score indicates a better treatment outcome.

  4. Pain intensity: subjective state

    Time frame: 1 day At stimulation visit

    PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.

  5. Depression scale: subjective state

    Time frame: 1 day At stimulation visit

    PROMIS scale of depression. Scores range from 1 (not at all depressed) to 5 (severely depressed). A lower score indicates a better treatment outcome.

  6. Anxiety scale: subjective state

    Time frame: 1 day At stimulation visit

    PROMIS scale of anxiety. Scores range from 1 (not at all anxious) to 5 (severely anxious). A lower score indicates a better treatment outcome.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects

Acronym: DBT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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