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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: Completed NA study of Crps I and Causalgia, sponsored by Millennium Pain Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in pain relative to baseline pain (i.e. prior to therapy) at 3 months after device activation for providing Intraspinal-Optimal Stim therapy. Pain scoring will be based on the 11-points (0 to 10) numerical pain rating scale. In this scale a value of 0 means no pain, and a value of 10 reflects the worst imaginable pain.
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 |
What the finished NCT03954080 record still lists
NCT03954080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954080's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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