Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01298609
First received: February 14, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Fibromyalgia
Device: Occipital Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Study to Examine the Efficacy of Greater Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: End of 6 week stimulation trial ] [ Designated as safety issue: No ]

    The Fibromyalgia Impact Questionnaire (FIQ) is a self administered scale that was developed to measure fibromyalgia patient status, progress and outcomes. It measures the components of health that are most affected by fibromyalgia. The maximum score is 100 and a higher score indicates a greater impact of the syndrome on the person.

    The change in the Fibromyalgia Impact Questionnaire (FIQ) will be analyzed and reported.



Enrollment: 40
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suprathreshold Stimulation
Patients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation
Device: Occipital Stimulation
Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
Sham Comparator: minimal stimulation
Patients will be stimulated at minimal stimulation for two weeks using occipital stimulation
Device: Occipital Stimulation
Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
Active Comparator: Subthreshold Stimulation
Patients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation
Device: Occipital Stimulation
Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients able to provide informed consent to participate in the study;
  2. Patient has had chronic widespread pain for at least 3 months in all 4 body quadrants;
  3. Patient has at least 11 out of 18 tender points based on the tender points examination;
  4. Patient has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to drugs, physical therapy, acupuncture, etc.);
  5. Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
  6. Psychological screening has been completed and the patient has been cleared by a psychologist as a suitable study candidate;
  7. Patient agrees not to add or increase medication throughout the randomization trial period of the study;
  8. Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.

Exclusion Criteria:

  1. Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics, (e.g. bipolar disorder, major depressive disorder);
  2. Patient has been diagnosed with any disease mimicking the symptoms of the Fibromyalgia Syndrome (e.g. Epstein Barr, autoimmune diseases, etc.) that is not currently being treated or has not been stable for at least 6 months;
  3. Patient is currently in active menopause;
  4. Patient has been diagnosed with sleep apnea and is not currently involved in a treatment regime;
  5. Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
  6. Patient currently participating in another clinical study;
  7. Patient with demand-type cardiac pacemakers, an infusion pump or any implantable neurostimulator device;
  8. Patient is likely to require an MRI evaluation in the future;
  9. Patient is not willing to maintain current medication regimen;
  10. Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298609

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Roni Diaz St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01298609     History of Changes
Other Study ID Numbers: CRD_545
Study First Received: February 14, 2011
Last Updated: May 22, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by St. Jude Medical:
Fibromyalgia
Occipital Nerve Stimulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014