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

Primary Purpose

Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verum stimulation with Diadem prototype
Sham stimulation with Diadem prototype
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation

Sham stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Target engagement: brain activation
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Target engagement: brain connectivity
Pearson's correlation of BOLD signals between the stimulated target and connected regions.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2023
Last Updated
September 21, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05674903
Brief Title
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
Acronym
DBT
Official Title
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype
Intervention Type
Device
Intervention Name(s)
Verum stimulation with Diadem prototype
Intervention Description
Diadem prototype device delivers focused low-intensity ultrasound stimulation
Intervention Type
Device
Intervention Name(s)
Sham stimulation with Diadem prototype
Intervention Description
Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation
Primary Outcome Measure Information:
Title
Target engagement: brain activation
Description
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Time Frame
1 day At MRI study visit
Title
Target engagement: brain connectivity
Description
Pearson's correlation of BOLD signals between the stimulated target and connected regions.
Time Frame
1 day At MRI study visit
Title
Pain intensity: momentary change
Description
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.
Time Frame
1 day At stimulation visit
Title
Pain intensity: subjective state
Description
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
Time Frame
1 day At stimulation visit
Title
Depression scale: subjective state
Description
PROMIS scale of depression. Scores range from 1 (not at all depressed) to 5 (severely depressed). A lower score indicates a better treatment outcome.
Time Frame
1 day At stimulation visit
Title
Anxiety scale: subjective state
Description
PROMIS scale of anxiety. Scores range from 1 (not at all anxious) to 5 (severely anxious). A lower score indicates a better treatment outcome.
Time Frame
1 day At stimulation visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Kubanek, PhD
Phone
801-213-1418
Email
jan.kubanek@utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Akiko Okifuji, PhD
Email
Akiko.Okifuji@hsc.utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akiko Okifuji
Email
Akiko.Okifuji@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jan Kubanek, PhD
First Name & Middle Initial & Last Name & Degree
Akiko Okifuji, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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