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

NCT05674903 | Completed Phase 1

• 1 other identifier: IRB_00162656
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Chronic Pain Syndrome; Widespread Chronic Pain

Outcome Measures

Primary Outcomes (6)

• Target engagement: brain activation

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

  1 day At MRI study visit

• Target engagement: brain connectivity

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

  1 day At MRI study visit

• Pain intensity: momentary change

  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.

  1 day At stimulation visit

• Pain intensity: subjective state

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

  1 day At stimulation visit

• Depression scale: subjective state

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

  1 day At stimulation visit

• Anxiety scale: subjective state

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

  1 day At stimulation visit

Study Arms (2)

Active stimulation

EXPERIMENTAL

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype

Device: Verum stimulation with Diadem prototype

Sham stimulation

SHAM COMPARATOR

Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype

Device: Sham stimulation with Diadem prototype

Interventions

Verum stimulation with Diadem prototype DEVICE

Diadem prototype device delivers focused low-intensity ultrasound stimulation

Active stimulation

Sham stimulation with Diadem prototype DEVICE

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

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Riis TS, Feldman DA, Losser AJ, Okifuji A, Kubanek J. Noninvasive targeted modulation of pain circuits with focused ultrasonic waves. Pain. 2024 Dec 1;165(12):2829-2839. doi: 10.1097/j.pain.0000000000003322. Epub 2024 Jul 30.

  PMID: 39073370 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 9, 2023
• Study Start: July 10, 2023
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)