Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

NCT01592344 | Completed Results

• 1 other identifier: CP-STMR11-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Pain

Keywords

Chronic pain; peripheral nerve; neuralgia; somatosensory nervous system

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%

  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.

  Baseline and at 3-month follow-up.

Secondary Outcomes (3)

• Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).

  at 3 month follow-up

• Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.

  at baseline and 3 month follow-up

• Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey

  at the 3-month follow-up

Study Arms (2)

StimRouter - active stimulation

EXPERIMENTAL

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

StimRouter - Control

SHAM COMPARATOR

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

Interventions

StimRouter - active stimulation DEVICE

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

Also known as: Bioness® StimRouter™ Neuromodulation System

StimRouter - active stimulation

StimRouter - Control DEVICE

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

Also known as: Bioness® StimRouter™ Neuromodulation System

StimRouter - Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 22 years) suitable for an implanted electrode for pain relief.
• Subjects who are able to give informed consent and to understand and comply with study requirements.
• 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).
• Subjects who are able to tolerate skin surface stimulation (TENS).
• 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.
• 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.

You may not qualify if:

• Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.
• Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.
• Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.
• 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.
• Subjects who require, or are likely to require, diathermy at the implant site.
• Subjects who require, or are likely to require, therapeutic ultrasound at the implant site.
• Subjects who have a cancerous lesion present near the target stimulation point or near to where the StimRouter user patch will adhere.
• Subjects who are known or suspected to have a nickel allergy.
• Subjects with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
• Subjects who decline to provide written consent or follow-up.
• 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.
• Subjects who have an active systemic infection or are immunocompromised.
• Subjects who have an active or existing skin disorder or irritation, which, at the physician's discretion, precludes the use of skin gel electrodes.
• Subjects who have a history of adverse reactions to local anesthetic (e.g., lidocaine).
• 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.

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (13)

Arizona Pain Specialists

Scottsdale, Arizona, 85258, United States

Location

Neurovations

Napa, California, 94558, United States

Location

Neuro-Therapeutics, Inc.

Pasadena, California, 91105, United States

Location

The Spine Institute, Center for Spinal Restoration

Santa Monica, California, 90403, United States

Location

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, 33334, United States

Location

Shands Jacksonville Medical Center, Dept of Neurology Research

Jacksonville, Florida, 32209, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Premier Pain Centers, LLC

Shrewsbury, New Jersey, 07702, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Center for Pain Relief, St. Francis Hospital

Charleston, West Virginia, 25301, United States

Location

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

Huntington, West Virginia, 25702, United States

Location

Related Links

• MedlinePlus related topics: Chronic pain
• US FDA Recourses

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

The device was designed for treatment of mononeuritis excluding the face. For this reason, mononeuropathies of the face were excluded.

Results Point of Contact

• Title: Charlene Myers, Contractor
• Organization: Bioness

cahanderson@msn.com

9499101655

Study Officials

• Linh Nguyen, MS

  Bioness Inc

  STUDY DIRECTOR

• Ramsin Benyamin, M.D.

  Millennium Pain Center

  PRINCIPAL INVESTIGATOR

• Timothy Deer, M.D.

  Center for Pain Relief, St. Francis Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: April 11, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-03

Locations

US (13)