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Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

NCT01298609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-30

No results posted yet for this study

Summary

The study is designed as a prospective, randomized, double-blind, single center study with a 6 month duration post permanent system implantation. Forty patients will be implanted.

During trial stimulation, patients will be randomized into one of two study arms for two weeks. Crossover will occur at the 2 week study visit to the opposite group. After completion of these two arms, every patient will subsequently complete participation in the third study arm.

After completion of the third arm, patients will be evaluated to determine if they are a positive responder responder. If so, the patient will have the option of obtaining the permanent implant.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Occipital Stimulation

Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Roni Diaz · Abbott Medical Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Belgium

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 NCT01298609 on ClinicalTrials.gov