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

• Sponsor: University of Utah (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05674903
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Chronic Pain Syndrome; Widespread Chronic Pain	Device: Verum stimulation with Diadem prototype; Device: Sham stimulation with Diadem prototype	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2026
• Anticipated Study Completion Date: Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active stimulation Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype	Device: Verum stimulation with Diadem prototype; Diadem prototype device delivers focused low-intensity ultrasound stimulation
Sham Comparator: Sham stimulation Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype	Device: Sham stimulation with Diadem prototype; Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation

Outcome Measures

Primary Outcome Measures

1. Target engagement: brain activation [1 day At MRI study visit]

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

2. Target engagement: brain connectivity [1 day At MRI study visit]

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

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Kubanek, Assistant Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT05674903
• Other Study ID Numbers: IRB_00162656
• First Posted: Jan 9, 2023
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Jan 9, 2023