Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02523092 · 14 participants · Phase 4

    Use of CXCL9 as a Biomarker of Acthar Efficacy

  • NCT04263285 · 14 participants · NA

    Treatment of Depression Post-SCI

  • NCT04743271 · 14 participants · NA

    Food and Circadian Timing

  • NCT05065671 · 14 participants · Phase 1

    Microbiome Derived Metabolism and Pharmacokinetics

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00294281, the US trial registry maintained by the National Library of Medicine. NCT00294281 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.