Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 6:06 PM
Study NCT ID:
NCT06421350
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Sponsor:
Scripps Health
Organization:
Study Overview
Official Title:
Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
Detailed Description:
After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: