NCT06297200 · Virginia Polytechnic Institute and State University
Low-Intensity Focused Ultrasound and the Complex Patient
What this study is about
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
View original scientific description
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Interventions
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.
Primary outcome measures
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
Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
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
Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Changes in Heart Rate (HR)
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
changes in HR compared pre/post LIFU and at follow up
Changes in Respiration Rate (RR)
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
changes in RR compared pre/post LIFU and at follow up
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 mood scale compared pre/post LIFU and at follow up
Changes in Blood Pressure (BP)
Time frame: Assessed per participant, over the course of participation - an average of 4 weeks
changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Roanoke, Virginia
Collaborators
Salem VA Medical Center, Washington DC VA Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 3, 2025 · Source of record for eligibility and locations