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

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ClinicalTrials.gov Identifier: NCT05674903
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Jan Kubanek, University of Utah

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Target engagement: brain activation [ Time Frame: 1 day At MRI study visit ]
    MRI quantification of blood oxygenation level dependent (BOLD) activation.

  2. Target engagement: brain connectivity [ Time Frame: 1 day At MRI study visit ]
    Pearson's correlation of BOLD signals between the stimulated target and connected regions.

  3. Pain intensity: momentary change [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05674903


Contacts
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Contact: Jan Kubanek, PhD 801-213-1418 jan.kubanek@utah.edu
Contact: Akiko Okifuji, PhD Akiko.Okifuji@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Akiko Okifuji       Akiko.Okifuji@hsc.utah.edu   
Principal Investigator: Jan Kubanek, PhD         
Principal Investigator: Akiko Okifuji, PhD         
Sponsors and Collaborators
University of Utah
More Information
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Responsible Party: Jan Kubanek, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT05674903    
Other Study ID Numbers: IRB_00162656
First Posted: January 9, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations