Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Closed-loop spinal cord stimulation for treating complex regional pain syndrome

Official title: Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Run by Scripps Health · NCT06421350 · Data updated 2026-11-12

This study is testing a new spinal cord stimulation method to see if it can help people with complex regional pain syndrome feel better, comparing those with recent symptoms to those with long-term pain.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment32 (estimated)
SponsorScripps Health
Academic / other
Locations1 site (La Jolla, California)
StatusRecruiting
StartedSeptember 3, 2024
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedNovember 3, 2025
Trial IDNCT06421350 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with unilateral CRPS type 1 or type 2 who have not previously undergone neuromodulation treatments.

Probably not a fit

Patients under 18 years old or those with prior neuromodulation treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of closed-loop spinal cord stimulation in patients with complex regional pain syndrome (CRPS) by comparing outcomes between those in the acute/subacute phase and those in the chronic phase. Participants will be divided into two groups based on the timing of their symptoms and will undergo a 7-day trial with a temporary spinal cord stimulator. If the device shows improvement in pain and function, a permanent device will be implanted. Patients will complete outcome assessments at baseline, after the trial, and at 3 and 6 months, along with blood tests to measure prolactin levels associated with pain and stress.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with complex regional pain syndrome.

How similar studies have gone: While spinal cord stimulation has been studied for pain management, this specific closed-loop approach in CRPS is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 18 years or older
* neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
* pre-procedure psychological clearance

Exclusion Criteria:

* younger than 18 years
* prior neuromodulation including spinal cord stimulation
* prior dorsal root ganglion stimulation
* prior peripheral nervous system stimulation
* anatomical obstacles to dorsal column lead placement

Where it's running

  • Scripps Clinic Torrey Pines
    La Jolla, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.