Low Intensity Focused Ultrasound to Treat Chronic Back Pain Targeting the Human Insula with High Precision

What this Trial Is About

Researchers are studying the use of low-intensity focused ultrasound LIFU to temporarily change brain activity in the posterior region of the insula, a brain area involved in chronic pain. This study focuses on people with chronic back pain CBP who also experience widespread pain symptoms. The goal is to understand how this brain region responds to pain and to evaluate the effects of LIFU compared to sham stimulation on pain intensity and neural responses to both evoked and tonic pain. The study uses a double-blind, randomized, sham-controlled crossover design involving 66 individuals with chronic back pain. Participants will receive LIFU targeting the posterior insula or sham stimulation in separate sessions. LIFU delivers focused acoustic energy noninvasively with high spatial precision to modulate brain activity safely. The sessions aim to measure how LIFU affects central sensitization processes and pain responses compared to sham treatment. Participants will undergo assessments immediately before and within one hour after each LIFU or sham session. These include measuring thermal pain threshold, temporal summation of pain, conditioned pain modulation, and neural signatures related to pain intensity. The research team will monitor changes in pain sensitivity and brain activity patterns to better understand LIFUs effects. The study will run from early 2025 to early 2028, with participants involved during each treatment and evaluation visit.

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