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Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia

NCT00294281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-09-20

No results posted yet for this 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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Vagus Nerve Stimulation (VNS) Therapy

The VNS Therapy System Pulse Generator is an implantable, multi-programmable bipolar pulse generator. The pulse generator will deliver electrical signals to the vagus nerve via bipolar leads. A programming wand and software system enable non-invasive programming, functional assessments, interrogation, and data retrieval.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Gudrun Lange, PhD · University of Medicine and Dentistry of New Jersey

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294281 on ClinicalTrials.gov