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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
low intensity focused ultrasound (LIFU)
DeviceLow-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: LIFU/ShamOther 1 intervention
Group B: Sham/LIFUOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
number of adverse events
Time frame
immediately prior to 1 session low-intensity focused ultrasound (LIFU) and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamSecondary outcomes
1
Heart rate variability
Continuous heart rate variability monitoring
Time frame
immediately prior to 1 session low-intensity focused ultrasound (LIFU) and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post sham2
Pain threshold
Numeric Pain Rating Scale (NPRS) Score: 0-10 0 = 'No pain' 10 = 'Worst pain imaginable'
Time frame
immediately prior to 1 session low-intensity focused ultrasound (LIFU) and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamSponsors and contacts
Click on the lead sponsor to view all of their trials.
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