Low-Intensity Focused Ultrasound and the Complex Patient

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297200
• Other study ID #: 24-050
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Jessica Florig, MPH
• Phone: 540-526-2261
• Email: jnw[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males and females aged 18-65 years

2. 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.

3. 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.

4. 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.

5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.

6. 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:

1. Evidence of neuropathic pain

2. Previous spine surgery

3. Current substance use disorder other than OUD or tobacco use disorder

4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder

5. Chronic Pain Conditions other than chronic back pain

6. Daily opiate use other than buprenorphine/methadone for OUD/pain control

7. Pregnant or breastfeeding

8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases

9. 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

10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)

11. 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

12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Salem VA Medical Center, Washington DC VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events via a neurological examination	Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.	Assessed per participant, over the course of participation - an average of 4 weeks
Primary	Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire	Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.	Assessed per participant, over the course of participation - an average of 4 weeks
Primary	Changes in Heart Rate (HR)	changes in HR compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Primary	Changes in Respiration Rate (RR)	changes in RR compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Primary	Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.	changes in mood scale compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Primary	Changes in Blood Pressure (BP)	changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks