Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation on Neuropathic Pain: Protocol for a Randomized,...

Area of Science:

• Neurology
• Pain Management
• Neuroscience

Background:

• Neuropathic pain (NP) is challenging to manage with conventional therapies due to limited efficacy and side effects.
• Noninvasive neuromodulation offers alternatives, but transcranial magnetic stimulation has limitations in reaching deep brain regions.
• Low-intensity transcranial focused ultrasound stimulation (TUS) allows precise deep brain targeting for neural modulation, showing promise in early studies.

Purpose of the Study:

• To evaluate the therapeutic effects and safety of repeated low-intensity TUS sessions in patients with neuropathic pain.
• To explore TUS' potential as a novel treatment for NP by targeting specific brain regions.

Main Methods:

• A randomized, participant-blinded, placebo-controlled trial involving 39 participants with NP.
• Participants receive weekly TUS sessions for 8 weeks, targeting either the primary motor cortex or posterior superior insula, or a sham procedure.
• Primary outcome is the change in weekly average pain intensity; secondary outcomes include various pain, quality of life, and neurophysiological measures.

Main Results:

• Enrollment began April 30, 2025, with 20 participants enrolled by February 28, 2026.
• Enrollment is ongoing, and final analysis will occur after follow-up and data verification.

Conclusions:

• This is the first randomized controlled trial to assess the long-term efficacy and safety of repeated low-intensity TUS for NP.
• The study will provide exploratory proof-of-concept data on TUS' clinical effectiveness for neuropathic pain management.