Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain
Conditions
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.
Interventions
DEVICEVerum stimulation with Diadem prototype
Diadem prototype device delivers focused low-intensity ultrasound stimulation
DEVICESham stimulation with Diadem prototype
Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target engagement: brain activation | 1 day At MRI study visit | MRI quantification of blood oxygenation level dependent (BOLD) activation. |
| Target engagement: brain connectivity | 1 day At MRI study visit | Pearson's correlation of BOLD signals between the stimulated target and connected regions. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed