Recruiting NCT06297200

Low-Intensity Focused Ultrasound and the Complex Patient

No phase Interventional Opioid Use Disorder Chronic Pain Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Low-Intensity Focused Ultrasound, Low-Intensity Focused Ultrasound - sham.
Who it may be relevant to: Registry conditions: Opioid Use Disorder, Chronic Pain, Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Device Low-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.
Device Low-Intensity Focused Ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Incidence of Treatment-Emergent Adverse Events via a neurological examination [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]
Changes in Heart Rate (HR) [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]
Changes in Respiration Rate (RR) [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]
Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale. [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]
Changes in Blood Pressure (BP) [Time frame: Assessed per participant, over the course of participation - an average of 4 weeks]

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT06297200 · 24-050