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

Chronic Pain Clinical Trial

— DBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674903
• Other study ID #: IRB_00162656
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 10, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: Jan Kubanek, PhD
• Phone: 801-213-1418
• Email: jan.kubanek[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Widespread Chronic Pain

Intervention

Device:
• Verum stimulation with Diadem prototype
Diadem prototype device delivers focused low-intensity ultrasound stimulation
• Sham stimulation with Diadem prototype
Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target engagement: brain activation	MRI quantification of blood oxygenation level dependent (BOLD) activation.	1 day At MRI study visit
Primary	Target engagement: brain connectivity	Pearson's correlation of BOLD signals between the stimulated target and connected regions.	1 day At MRI study visit
Primary	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
Primary	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
Primary	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
Primary	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