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Mechanisms of Stimulation for Pain Alleviation

Trial ID or NCT#

NCT06741579

Status

not recruiting iconNOT RECRUITING

Purpose

This is a mechanistic randomized controlled trial of 134 patients with lower extremity chronic neuropathic pain randomized to stable conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). All participants will undergo baseline and monthly remote assessments for up to 1 year. Quantitative sensory testing (QST) will be performed in all participants at baseline, 30 days, and 3 months, with an additional QST session in PNS implanted patients at 6 months. The local expression of sigma-1 receptors in chronic pain allows for visualization of peripheral pain generators, and the investigators will utilize a novel PET radiotracer highly selective for the sigma-1 receptor correlating with local receptor density and pain symptoms. 78 patients (39 in each arm, only at Stanford) will undergo \[18F\]FTC-146 PET/ MRI at baseline. 5 patients will also receive PET/CT of the lower extremities at baseline. These 78 patients will also receive \[18F\]FTC-146 PET/CT at 3 months. The investigators will characterize treatment interactions with participant attributes and baseline QST pain sensitivity measures in predicting treatment response; examine depression and physical function as mediators of treatment response; compare longitudinal pain, depressive symptom, pain catastrophizing, physical function, and QST trajectories across treatments, compare acute QST responses to PNS after stable implantation, and determine whether peripheral imaging markers correlate with baseline pain and treatment response.

Official Title

Mechanisms of Stimulation for Pain Alleviation

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Jennifer Hah
Jennifer Hah
Pain management specialist
Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain)

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Contact

Saneel Khairnar
650-713-1795