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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00294281
The ClinicalTrials.gov registry entry for NCT00294281 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vagus Nerve Stimulation (VNS) Therapy is the first listed.
NCT00294281 reports 0 study locations.
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.
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