Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT01592344
First received: May 3, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention
Chronic Pain
Device: SR-electrical stimulation (Bioness) and pain medication
Device: SR-Control electrical stimulation (Bioness) & pain meds during first 3 mos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Prospective, Multi-Center, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Bioness® StimRouter™ Neuromodulation System in the Treatment for Patients With Chronic Pain of Peripheral Nerve Origin

Resource links provided by NLM:


Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • The average pain at rest will be assessed using 7-day patient pain diary scores for Brief Pain Inventory (BPI) Short Form (SF) (mean pain at baseline and at 3-month follow-up visit). [ Time Frame: at baseline and at 3-month follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Pain Medication [ Time Frame: at baseline, and 1, 2, 3, 6, and 12-month follow-up ] [ Designated as safety issue: No ]
  • Quality of Life will be assessed by using the SF-12v2™ Health Survey. [ Time Frame: at baseline and 3-month follow-up ] [ Designated as safety issue: No ]
  • Patient global impression of improvement with treatment will be assessed using the Patient Global Impression of Change scale (PGIC). [ Time Frame: at 3, 6, and 12-month follow-up ] [ Designated as safety issue: No ]
  • 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 1, 2, 3, 6, and 12-month follow-up ] [ Designated as safety issue: No ]
  • The interference of pain with physical and emotional functioning will be assessed using 7-day patient pain diary scores for BPI SF #9. [ Time Frame: at baseline, and 1, 2, 3, 6, and 12-month follow-up ] [ Designated as safety issue: No ]
  • 6) Patient Satisfaction will be assessed using a patient satisfaction survey [ Time Frame: at the 3-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SR-electrical stimulation (Bioness)
SR-electrical stimulation (Bioness) device and pain medication for 12 months.
Device: SR-electrical stimulation (Bioness) and pain medication

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: SR-Control
SR-Control (sham electrical stimulation) and pain medication during first three months after randomization, and SR-electrical stimulation (Bioness) device and pain medication for the following nine months.
Device: SR-Control electrical stimulation (Bioness) & pain meds during first 3 mos

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

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 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. Then, 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. While the end of the study is approximately 12 months after randomization, the primary efficacy analysis will be based on the data collected at the end of the 3-month follow-up evaluation.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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
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: NCT01592344

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:
No publications provided

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01592344     History of Changes
Other Study ID Numbers: CP-STMR11-001
Study First Received: May 3, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bioness Inc:
Chronic pain
peripheral nerve
neuralgia
somatosensory nervous system

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014