Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy
NCT ID: NCT01592344
Last Updated: 2016-04-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2012-04-30
2015-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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
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.
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Bioness Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Linh Nguyen, MS
Role: STUDY_DIRECTOR
Bioness Inc
Ramsin Benyamin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Millennium Pain Center
Timothy Deer, M.D.
Role: STUDY_CHAIR
Center for Pain Relief, St. Francis Hospital
Locations
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Arizona Pain Specialists
Scottsdale, Arizona, United States
Neurovations
Napa, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
The Spine Institute, Center for Spinal Restoration
Santa Monica, California, United States
Holy Cross Orthopedic Institute
Fort Lauderdale, Florida, United States
Shands Jacksonville Medical Center, Dept of Neurology Research
Jacksonville, Florida, United States
Millennium Pain Center
Bloomington, Illinois, United States
Premier Pain Centers, LLC
Shrewsbury, New Jersey, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Center for Pain Relief, St. Francis Hospital
Charleston, West Virginia, United States
The Center for Pain Relief at St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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Related Links
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MedlinePlus related topics: Chronic pain
US FDA Recourses
Other Identifiers
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CP-STMR11-001
Identifier Type: -
Identifier Source: org_study_id
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