Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
This study is testing a new type of spinal cord stimulation device for Complex Regional Pain Syndrome (CRPS). The device uses a "closed-loop" system, meaning it adjusts its stimulation based on your body's real-time response. Researchers want to see if this device works better when CRPS is diagnosed early (acute or subacute phase) compared to when it's been present for a long time (chronic phase). You may be able to join if you are 18 or older, have CRPS type 1 or 2, and have not had other nerve stimulation treatments before. The study will measure changes in your CRPS severity scores and how the device's settings change over time to see if the treatment is successful. The current status of this study is unclear.
- Study design
- This study plans to enroll 32 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- You would first have a 7-day trial period with a temporary spinal cord stimulator. If it helps, a permanent device would be implanted. You will complete questionnaires at baseline, after the trial, and at 3 and 6 months, and have blood drawn at baseline, after the trial, and at 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the device is implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- David B Hiller, MD · PRINCIPAL_INVESTIGATOR · Physician
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Complex Regional Pain Syndrome Severity ScoresBaseline, 7 day trial period, 3 months, 6 months
(CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.
- Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device7 day trial period, 3 months, and 6 months.
Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.