NCT01298609

Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

A Randomized Controlled Pilot Study to Examine the Efficacy of Greater Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-02-17
• Last updated: 2019-01-30

Locations

1 site across 1 country: Belgium