NCT01592344

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Bioness Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	StimRouter - active stimulation	The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 100-250 µsec * Pulse Rate: 50-100 Hz * Intensity: 0-30mA Time Settings * Constant Stim: On * Total Time: 6 hour
DEVICE	StimRouter - Control	The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 200 µsec * Pulse Rate: 1 Hz * Intensity: 0 mA Time Settings * Constant Stim: On * Total Time: 6 hour

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-10-01
• Completion: 2015-07-01
• First posted: 2012-05-07
• Last updated: 2016-04-11
• Results posted: 2016-03-14

Locations

13 sites across 1 country: United States