Focused Ultrasound for the Complex Patient

NCT06453109 | Recruiting DMC FDA Device

• 2 other identifiers: 1777666UG3DA059407
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Opioid Use Disorder; Chronic Back Pain; Anxiety

Keywords

anxiety disorders; oud; opiate use disorder; opioid; back pain; chronic back pain; opioid use; opioid abuse; opioid disorder; low intensity focused ultrasound; transcranial ultrasound

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  number of adverse events

  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 sham

Secondary Outcomes (2)

• Heart rate variability

  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 sham

• Pain threshold

  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 sham

Study Arms (2)

LIFU/Sham

OTHER

double-blind, sham-controlled, crossover study in N=25 individuals with opiate use disorder, anxiety, and chronic back pain

Device: low intensity focused ultrasound (LIFU)

Sham/LIFU

OTHER

double-blind, sham-controlled, crossover study in N=25 individuals with opiate use disorder, anxiety, and chronic back pain

Device: low intensity focused ultrasound (LIFU)

Interventions

low intensity focused ultrasound (LIFU) DEVICE

Low-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.

LIFU/Sham; Sham/LIFU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Meet the DSM-5 criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
• Be in treatment for OUD including buprenorphine or methadone.
• 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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5).

You may not qualify if:

• 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
• Daily use of benzodiazepines or opiates (other than buprenorphine or methadone)
• History of seizures, neurologic disorders, including cerebrovascular disease, history of stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases. They will not have 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.
• Ferromagnetic implants or other contraindications for MRI
• Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active systemic infection end stage renal disease.

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Washington DC Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders; Back Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary R Lee, MD

  Washington D.C. Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary R Lee, MD

CONTACT

202-745-8000; mary.lee3@va.gov

Krystian Burum, MS

CONTACT

krystian.burum@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sham condition will be conducted using an interface which does not allow ultrasound energy to pass from the transducer to the target. The administration of LIFU/sham will be conducted in a double-blind fashion.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: within subject, randomized, double-blind, sham-controlled trial

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: April 29, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: data will be available after analysis of primary and secondary outcomes are completed

Locations

US (1)