Actively Recruiting
Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Led by Scripps Health · Updated on 2025-11-03
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a closed-loop spinal cord stimulator works to treat complex regional pain syndrome (CRPS), comparing its effects when applied early in the acute or subacute phases versus the chronic phase. This study aims to understand differences in treatment responses to improve management of CRPS, a condition characterized by persistent pain and nervous system changes. It is an interventional trial led by Scripps Health focusing on this specialized device. Participants diagnosed with either acute or subacute CRPS will be assigned to one group, while those with chronic CRPS will be assigned to another. All participants will undergo a 7-day trial period using a temporary spinal cord stimulator. If the device improves pain and function during this trial, a permanent device will be implanted. The closed-loop system adjusts stimulation based on real-time physiological responses to address inflammation and nerve dysfunction associated with CRPS. During the study, participants will complete outcome questionnaires at baseline, after the trial, and at 3 and 6 months. Blood samples will be taken to measure prolactin levels related to stress and pain at baseline, after the trial, and at 3 months. Researchers will assess changes in CRPS severity, stimulation device parameters, pain levels, quality of life, anxiety, depression, and medication use. The total participation includes these follow-up periods to monitor treatment impact and safety.
CONDITIONS
Brief Title
Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Neuromodulation naive patients with unilateral CRPS type 1 or type 2 defined by Budapest Criteria
- Psychological clearance before procedure
You will not qualify if you...
- Younger than 18 years
- Prior neuromodulation including spinal cord stimulation
- Prior dorsal root ganglion stimulation
- Prior peripheral nervous system stimulation
- Anatomical obstacles preventing dorsal column lead placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants undergo a 7-day trial period with a temporary spinal cord stimulator to assess improvement in pain and function.
1 visit to implant temporary device and monitoring during trial period
Duration - Until study completion at 6 months
Participants with a positive trial period outcome have a permanent spinal cord stimulator implanted.
1 visit for permanent device implantation and follow-up assessments
Duration - 6 months
Participants complete outcome assessments including pain, quality of life, and blood tests at baseline, end of trial period, 3 months, and 6 months.
Visits at baseline, end of trial period, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
J
Julie C McCauley
R
Roslyn M Kackman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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