Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

• ClinicalTrials.gov Identifier: NCT01592344
• Recruitment Status: Completed
• First Posted: May 7, 2012
• Results First Posted: March 14, 2016
• Last Update Posted: April 11, 2016
• Sponsor: Bioness Inc
• Information provided by (Responsible Party): Bioness Inc

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: StimRouter - active stimulation; Device: StimRouter - Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: 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
• Study Start Date: April 2012
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: StimRouter - active stimulation; StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.	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; Other Name: Bioness® StimRouter™ Neuromodulation System
Sham Comparator: StimRouter - Control; StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.	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; Other Name: Bioness® StimRouter™ Neuromodulation System

Outcome Measures

Primary Outcome Measures :

1. Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30% [ Time Frame: Baseline and at 3-month follow-up. ]
   The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.

Secondary Outcome Measures :

1. Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC). [ Time Frame: at 3 month follow-up ]
   Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).
2. Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3. [ Time Frame: at baseline and 3 month follow-up ]
   Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine". Change from baseline to Month 3 was compared.
3. Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey [ Time Frame: at the 3-month follow-up ]
   Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Arizona Pain Specialists

Scottsdale, Arizona, United States, 85258

United States, California

Neurovations

Napa, California, United States, 94558

Neuro-Therapeutics, Inc.

Pasadena, California, United States, 91105

The Spine Institute, Center for Spinal Restoration

Santa Monica, California, United States, 90403

United States, Florida

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, United States, 33334

Shands Jacksonville Medical Center, Dept of Neurology Research

Jacksonville, Florida, United States, 32209

United States, Illinois

Millennium Pain Center

Bloomington, Illinois, United States, 61701

United States, New Jersey

Premier Pain Centers, LLC

Shrewsbury, New Jersey, United States, 07702

United States, North Carolina

The Center for Clinical Research

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Washington

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

United States, West Virginia

Center for Pain Relief, St. Francis Hospital

Charleston, West Virginia, United States, 25301

The Center for Pain Relief at St. Mary's Medical Center

Huntington, West Virginia, United States, 25702

Sponsors and Collaborators

Bioness Inc

Investigators

• Study Director: Linh Nguyen, MS; Bioness Inc
• Principal Investigator: Ramsin Benyamin, M.D.; Millennium Pain Center
• Study Chair: Timothy Deer, M.D.; Center for Pain Relief, St. Francis Hospital

More Information

Additional Information:

MedlinePlus related topics: Chronic pain 

US FDA Recourses 

• Responsible Party: Bioness Inc
• ClinicalTrials.gov Identifier: NCT01592344
• Other Study ID Numbers: CP-STMR11-001
• First Posted: May 7, 2012
• Results First Posted: March 14, 2016
• Last Update Posted: April 11, 2016
• Last Verified: March 2016

Keywords provided by Bioness Inc:

Chronic pain; peripheral nerve; neuralgia; somatosensory nervous system

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations