Closed-loop spinal cord stimulation for treating complex regional pain syndrome
Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scripps Health Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06421350 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old or those with prior neuromodulation treatments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
La Jolla, California
- Scripps Clinic Torrey Pines — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: David B Hiller, MD — Physician
- Study coordinator: Julie C McCauley
- Email: mccauley.julie@scrippshealth.org
- Phone: 585-554-7122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.