Actively Recruiting
Focused Ultrasound for the Complex Patient
Led by Washington D.C. Veterans Affairs Medical Center · Updated on 2024-11-20
25
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
W
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain * the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.
CONDITIONS
Official Title
Focused Ultrasound for the Complex Patient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18-75 years
- Current diagnosis of chronic back pain lasting at least three months, with pain present at least half the days in the past six months
- Evidence of central sensitization based on Widespread Pain Index and Symptom Severity scores
- Pain intensity rating of 4/10 or higher on the Brief Pain Inventory-Short Form
- Meet DSM-5 criteria for current opioid use disorder as diagnosed by a structured clinical interview
- Currently receiving treatment for opioid use disorder including buprenorphine or methadone
- Meet DSM-5 criteria for a current anxiety disorder (generalized anxiety disorder, PTSD, or social anxiety disorder) diagnosed by a structured clinical interview
You will not qualify if you...
- Evidence of neuropathic pain
- Current substance use disorder other than opioid use disorder or tobacco use disorder
- Current diagnosis of schizophrenia or schizo-affective disorder
- Pregnant or breastfeeding
- Daily use of benzodiazepines or opiates other than buprenorphine or methadone
- History of seizures or neurological disorders including stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
- History of metastasizing cancers or inflammatory disorders such as rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
- Unintended weight loss of 20 pounds or more in the last year
- Cauda equina syndrome
- Ferromagnetic implants or other contraindications for MRI
- Unstable medical conditions including congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection, or end stage renal disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
Research Team
M
Mary R Lee, MD
CONTACT
K
Krystian Burum, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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