Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia

NCT ID: NCT01298609

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Suprathreshold Stimulation

Patients will be stimulated at supra-sensory threshold levels for two weeks using occipital stimulation

Group Type: ACTIVE_COMPARATOR

Occipital Stimulation

Intervention Type: DEVICE

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

minimal stimulation

Patients will be stimulated at minimal stimulation for two weeks using occipital stimulation

Group Type: SHAM_COMPARATOR

Occipital Stimulation

Intervention Type: DEVICE

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

Subthreshold Stimulation

Patients will be stimulated at sub-sensory threshold stimulation for two weeks using occipital stimulation

Group Type: ACTIVE_COMPARATOR

Occipital Stimulation

Intervention Type: DEVICE

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

Interventions

Occipital Stimulation

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roni Diaz

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

CRD_545

Identifier Type: -

Identifier Source: org_study_id