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

Phase 1

Suspended

• Conditions: Widespread Chronic Pain; Chronic Pain; Chronic Pain Syndrome
• Interventions: Device: Verum stimulation with Diadem prototype; Device: Sham stimulation with Diadem prototype

• Registration Number: NCT05674903
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-09
• Study Start: 2023-07-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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 current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
5. 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
6. Capacity to provide informed consent; provision of a signed and dated consent form

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 study team

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation	Verum stimulation with Diadem prototype	Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype
Sham stimulation	Sham stimulation with Diadem prototype	Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype

Primary Outcome Measures

Name	Time	Method
Pain intensity: momentary change	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.
Pain intensity: subjective state	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.
Target engagement: brain activation	1 day At MRI study visit	MRI quantification of blood oxygenation level dependent (BOLD) activation.
Anxiety scale: subjective state	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.
Target engagement: brain connectivity	1 day At MRI study visit	Pearson's correlation of BOLD signals between the stimulated target and connected regions.
Depression scale: subjective state	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States