Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

Prospective, Multi-Center, Randomized, Double-Blinded, Study to Assess Safety and Efficacy of the Bioness® StimRouter™ Neuromodulation System in Patients With Chronic Pain of Peripheral Nerve Origin

The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.

Ninety (minimum) up to one hundred twenty-six (126) adult (≥ 22 years) subjects who have severe intractable chronic pain of peripheral nerve origin associated with post traumatic/post surgical neuralgia persisting for 3 months or longer and an average chronic pain level of at least 5 on a 0-10 numeric rating scale, where such pain is attributable to a lesion or disease of the somatosensory nervous system, will be recruited from U.S. outpatient physical medicine and rehabilitation clinics.

After screening, subjects who were confirmed to be eligible for the study and provided informed consent will have a pain level assessment period for approximately one week then come back for the Baseline/Implantation visit. Subjects will be trained on and required to complete a patient diary of pain intensity level for at least 7 consecutive days prior to baseline. The randomization and programming will take place approximately two weeks after implantation. Subjects in the treatment group will receive electrical stimulation and pain medication. In contrast, subjects in the parallel control group will receive control stimulation and pain medication.

The plan is to have the parallel portion of the study run for approximately 12 weeks (or 3 months) after randomization for efficacy analysis. Subjects in the control group will be allowed to cross over to the treatment group for nine months of electrical stimulation; the subjects in the treatment group will have nine additional months of stimulation treatment such that safety data will be collected throughout a full twelve month period on all available subjects. While the end of the study is approximately 12 months after randomization, as previously stated, the efficacy analyses will be based on the data collected at the end of the 3-month follow-up evaluation.

Inclusion Criteria:

1. Adults (≥ 22 years) suitable for an implanted electrode for pain relief.
2. Subjects who are able to give informed consent and to understand and comply with study requirements.
3. Subjects who have severe intractable chronic pain of peripheral nerve origin associated with post traumatic/post surgical neuralgia for ≥ 3 months (i.e., intractable to pain medication).
4. Subjects who are able to tolerate skin surface stimulation (TENS).
5. Subjects who have a worst chronic pain level in the last 24 hours ≥ 5/10 (on 0-10 NRS) where such pain is attributable to a lesion or disease of the somatosensory nervous system.
6. Subjects who are on a stable dose of pain medications for at least four weeks prior to screening and willing and able to maintain an equivalent dosage of their current pain medications from randomization to 3-month follow-up.

Exclusion Criteria:

1. Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.
2. Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.
3. Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.
4. Subjects who have a metal implant in the area for StimRouter implantation without Sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices and metallic implants.
5. Subjects who require, or are likely to require, diathermy at the implant site.
6. Subjects who require, or are likely to require, therapeutic ultrasound at the implant site.
7. Subjects who have a cancerous lesion present near the target stimulation point or near to where the StimRouter user patch will adhere.
8. Subjects who are known or suspected to have a nickel allergy.
9. Subjects with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
10. Subjects who decline to provide written consent or follow-up.
11. Subjects who are pregnant, plan on becoming pregnant, or are breastfeeding during the study period. Subjects who are female of child-bearing potential must have a negative pregnancy test at baseline visit and, if sexually active, must be using a medically acceptable method of contraception for the duration of the study participation.
12. Subjects who have an active systemic infection or are immunocompromised.
13. Subjects who have an active or existing skin disorder or irritation, which, at the physician's discretion, precludes the use of skin gel electrodes.
14. Subjects who currently require or are likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MR system's bore (the iso-center) and at least 16 cm outside of the MR coil measured from the edge of the MR coil.
15. Subjects who have a history of adverse reactions to local anesthetic (e.g., lidocaine).
16. Subjects who are participating in any other study that could affect the outcome of the StimRouter study, such as a spinal stimulation study, without Sponsor approval.
17. Subjects who are in litigation or who have pending or an active worker's compensation claim.
18. Subjects with less than one year of life expectancy.