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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

Tracking Information
First Submitted Date  ICMJE January 3, 2023
First Posted Date  ICMJE January 9, 2023
Last Update Posted Date September 26, 2023
Actual Study Start Date  ICMJE July 10, 2023
Estimated Primary Completion Date March 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2023)
  • Target engagement: brain activation [ Time Frame: 1 day At MRI study visit ]
    MRI quantification of blood oxygenation level dependent (BOLD) activation.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
Official Title  ICMJE Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Chronic Pain Syndrome
  • Widespread Chronic Pain
Intervention  ICMJE
  • Device: Verum stimulation with Diadem prototype
    Diadem prototype device delivers focused low-intensity ultrasound stimulation
  • Device: Sham stimulation with Diadem prototype
    Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation
Study Arms  ICMJE
  • Experimental: Active stimulation
    Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype
    Intervention: Device: Verum stimulation with Diadem prototype
  • Sham Comparator: Sham stimulation
    Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype
    Intervention: Device: Sham stimulation with Diadem prototype
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2023)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2026
Estimated Primary Completion Date March 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan Kubanek, PhD 801-213-1418 jan.kubanek@utah.edu
Contact: Akiko Okifuji, PhD Akiko.Okifuji@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05674903
Other Study ID Numbers  ICMJE IRB_00162656
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jan Kubanek, University of Utah
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Utah
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP