Low-Intensity Focused Ultrasound For Insular Neuromodulation in Chronic Pain

NCT05751096 | Unknown FDA Device

• 1 other identifier: IRB-22-1597
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Study investigating the potential benefit for chronic pain patients (CRPS and FM) using low-intensity focused ultrasound for neuromodulation.

Conditions

Fibromyalgia; Complex Regional Pain Syndromes; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Perceived Pain scores

  Patients will rate their perceived pain (on a 0-9 scale, no pain - severe pain) before and after application of LIFU or Sham

  through study completion, an average of 2 weeks.

Secondary Outcomes (2)

• Clinical outcome - skin temperature

  through study completion, an average of 2 weeks

• Clinical outcomes - circumference

  through study completion, an average of 2 weeks

Study Arms (4)

LIFU - CRPS

ACTIVE COMPARATOR

Real LIFU application for CRPS cohort.

Device: Low-intensity Focused Ultrasound (LIFU)

SHAM - CRPS

SHAM COMPARATOR

Sham LIFU application for CRPS cohort.

Device: Sham Low-intensity focused ultrasound (LIFU)

LIFU - FM

ACTIVE COMPARATOR

Real LIFU application for FM cohort.

Device: Low-intensity Focused Ultrasound (LIFU)

SHAM - FM

SHAM COMPARATOR

Sham LIFU application for FM cohort.

Device: Sham Low-intensity focused ultrasound (LIFU)

Interventions

Low-intensity Focused Ultrasound (LIFU) DEVICE

repeat pulse application of low intensity focused ultrasound using a single element transducer to a selected neurological target for neuromodulation.

LIFU - CRPS; LIFU - FM

Sham Low-intensity focused ultrasound (LIFU) DEVICE

Sham application of LIFU.

SHAM - CRPS; SHAM - FM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of complex regional pain syndrome (CRPS) I or II (Budapest Criteria) by Carilion physician. OR Diagnosis of fibromyalgia (FM) by Carilion physician (American College of Radiology 2011 modified fibromyalgia criteria).

You may not qualify if:

• Contraindications to MRI.
• Contraindications to CT
• History of seizures and/or pseudo-seizures

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Complex Regional Pain Syndromes; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Stringer, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Florig, MPH

CONTACT

540-526-2261; jnw@vtc.vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: LIFU vs SHAM application study visit will appear identical to study participants.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will act as their own control with a cross over study design. LIFU application vs Sham will be applied on separate study days for both pain cohorts (FM and CRPS).

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 2, 2023
• Study Start: July 15, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)