Focused Ultrasound for the Complex Patient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWashington D.C. Veterans Affairs Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Males and females aged 18-75 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.
Participants must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPI-SF)
Disqualifiers
Evidence of neuropathic pain
Current DSM-5 substance use disorder other than OUD, tobacco use disorder
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Pregnant or breastfeeding
Trial design
Treatments tested in this trial
- low intensity focused ultrasound (LIFU)
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington D.C. Veterans Affairs Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov