RECRUITING

Low-Intensity Focused Ultrasound and the Complex Patient

Conditions

Opioid Use Disorder Chronic Pain Anxiety Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-04

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06297200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Jessica Florig, MPH

CONTACT

540-526-2261

jnw@vtc.vt.edu

Study Locations (Sites)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016

United States

Collaborators and Investigators

Sponsor: Virginia Polytechnic Institute and State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-12-04

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use Disorder
Chronic Pain
Anxiety Disorder