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NCT03954080 · ClinicalTrials.gov registry record · NA
Trialing of ISS in Patients With CRPS
A NA study of Crps I and Causalgia, sponsored by Millennium Pain Center.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03954080 is a NA study of Crps I and Causalgia that has completed, run by Millennium Pain Center. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03954080, a NA study of Crps I and Causalgia, has completed, sponsored by Millennium Pain Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study. A standard of care trial phase to test a subjects' response to Intraspinal-Optimal Stim therapy will be conducted during a 3 to 10-day period. Patients that obtain 50% or greater pain relief during the trial period will undergo permanent implantation of the device. Primary outcome will evaluate pain response at 3 months of therapy, based on NPRS pain score relative to baseline. Patients will be followed up for 6 months after the start of therapy.
Interventions
- DEVICE Intraspinal-optimal stim therapy
Study Locations (1)
Illinois
- Millennium Pain Center - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2022-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03954080
The ClinicalTrials.gov registry entry for NCT03954080 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pain Center, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Crps I appearing as the primary indexed condition, and to 1 intervention - of which Intraspinal-optimal stim therapy is the first listed.
NCT03954080 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03954080 about?
NCT03954080 is a clinical study titled "Trialing of ISS in Patients With CRPS". This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I o...
What is the current status of trial NCT03954080?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2019-06-13. Estimated completion is 2022-03-31.
What conditions does trial NCT03954080 study?
This clinical trial studies the following conditions: Crps I, Causalgia.
What interventions are being tested in trial NCT03954080?
The interventions under investigation include: Intraspinal-optimal stim therapy (DEVICE).
Who is sponsoring clinical trial NCT03954080?
This trial is sponsored by Millennium Pain Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03954080 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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