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NCT00294281 · ClinicalTrials.gov registry record · Phase 1
Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia
A Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00294281: Completed Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT00294281 is a Phase 1 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00294281, a Phase 1 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms associated with the disorder include fatigue and depression. The cause of FMS is unknown, and conventional treatments are often unsuccessful in adequately relieving pain. For people with severe, unrelenting pain, which is referred to as refractory FMS, opioid maintenance therapy may be an option, but it comes with the dangerous potential of addiction and is therefore avoided if possible. Vagus nerve stimulation (VNS), in which a nerve located in the neck receives electrical input, may be an option for providing pain relief. The purpose of this study is to determine the safety, tolerability, and effectiveness of VNS as a treatment for people with refractory FMS.
Interventions
- DEVICE Vagus Nerve Stimulation (VNS) Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00294281 record still lists
NCT00294281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Vagus Nerve Stimulation (VNS) Therapy is the first listed.
NCT00294281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00294281 about?
NCT00294281 is a clinical study titled "Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia". Fibromyalgia syndrome (FMS) is a long-term disorder that is characterized by widespread body pain and tender points in joints, muscles, tendons, and other soft tissues. Other symptoms associated with the disorder include fatigue and depression. The cause of FMS is unknown, and conventional treatment...
What is the current status of trial NCT00294281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2006-10. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00294281?
The interventions under investigation include: Vagus Nerve Stimulation (VNS) Therapy (DEVICE).
Who is sponsoring clinical trial NCT00294281?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00294281's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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