Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer: * The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• Veterans aged 21 to 75 with Chronic Back Pain (CBP).

• CBP duration daily for last 3 months or half of days for last 6 months

• Endorse pain rating of 4/10 BPI-SF

• Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.

Locations
United States
Washington, D.c.
Washington DC Veterans Affairs Medical Center
RECRUITING
Washington D.c.
Contact Information
Primary
Mary R Lee, MD
mary.lee3@va.gov
202-745-8000
Backup
Evan Evan Lindeman, MS
evan.lindeman@va.gov
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2028-01-26
Participants
Target number of participants: 66
Treatments
Other: LIFU/Sham
double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain
Other: Sham/LIFU
double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain
Related Therapeutic Areas
Sponsors
Leads: Washington D.C. Veterans Affairs Medical Center

This content was sourced from clinicaltrials.gov