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

University of Utah47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain Chronic Pain Syndrome Widespread Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Target engagement: brain activation

MRI quantification of blood oxygenation level dependent (BOLD) activation.

Time frame: 1 day At MRI study visit

Target engagement: brain connectivity

Pearson's correlation of BOLD signals between the stimulated target and connected regions.

Time frame: 1 day At MRI study visit

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.

Time frame: 1 day At stimulation visit

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.

Time frame: 1 day At stimulation visit

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.

Time frame: 1 day At stimulation visit

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.

Time frame: 1 day At stimulation visit

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes