RecruitingNot ApplicableNCT06297200

Low-Intensity Focused Ultrasound and the Complex Patient

Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient

Sponsor

Virginia Polytechnic Institute and State University

Enrollment

25 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Opioid-use Disorder Anxiety Disorder

Summary

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

Males and females aged 18-65 years
Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.

Exclusion Criteria12

Evidence of neuropathic pain
Previous spine surgery
Current substance use disorder other than OUD or tobacco use disorder
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Chronic Pain Conditions other than chronic back pain
Daily opiate use other than buprenorphine/methadone for OUD/pain control
Pregnant or breastfeeding
History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease

Interventions

DEVICELow-Intensity Focused Ultrasound

A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.

DEVICELow-Intensity Focused Ultrasound - sham

A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.