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Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

StimRouter - active stimulation

StimRouter - Control

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Chronic pain, peripheral nerve, neuralgia, somatosensory nervous system

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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 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.
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.
Subjects who are in litigation or who have pending or an active worker's compensation claim.
Subjects with less than one year of life expectancy.

Sites / Locations

Arizona Pain Specialists
Neurovations
Neuro-Therapeutics, Inc.
The Spine Institute, Center for Spinal Restoration
Holy Cross Orthopedic Institute
Shands Jacksonville Medical Center, Dept of Neurology Research
Millennium Pain Center
Premier Pain Centers, LLC
The Center for Clinical Research
Cleveland Clinic
Virginia Mason Medical Center
Center for Pain Relief, St. Francis Hospital
The Center for Pain Relief at St. Mary's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

StimRouter - active stimulation

StimRouter - Control

Arm Description

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- 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

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

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.

Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey

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.

Full Information

NCT ID

NCT01592344

First Posted

May 3, 2012

Last Updated

March 11, 2016

Sponsor

Bioness Inc

1. Study Identification

Unique Protocol Identification Number

NCT01592344

Brief Title

Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

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 Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioness Inc

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Chronic pain, peripheral nerve, neuralgia, somatosensory nervous system

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

StimRouter - active stimulation

Arm Type

Experimental

Arm Description

Arm Title

StimRouter - Control

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

StimRouter - active stimulation

Other Intervention Name(s)

Bioness® StimRouter™ Neuromodulation System

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

StimRouter - Control

Other Intervention Name(s)

Bioness® StimRouter™ Neuromodulation System

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and at 3-month follow-up.

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

at 3 month follow-up

Title

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

Description

Time Frame

at baseline and 3 month follow-up

Title

Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey

Description

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.

Time Frame

at the 3-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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. 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. Subjects who are in litigation or who have pending or an active worker's compensation claim. Subjects with less than one year of life expectancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linh Nguyen, MS

Organizational Affiliation

Bioness Inc

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ramsin Benyamin, M.D.

Organizational Affiliation

Millennium Pain Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Timothy Deer, M.D.

Organizational Affiliation

Center for Pain Relief, St. Francis Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Arizona Pain Specialists

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Neurovations

City

Napa

State/Province

California

ZIP/Postal Code

94558

Country

United States

Facility Name

Neuro-Therapeutics, Inc.

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

The Spine Institute, Center for Spinal Restoration

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

Facility Name

Holy Cross Orthopedic Institute

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

Shands Jacksonville Medical Center, Dept of Neurology Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Millennium Pain Center

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

Facility Name

Premier Pain Centers, LLC

City

Shrewsbury

State/Province

New Jersey

ZIP/Postal Code

07702

Country

United States

Facility Name

The Center for Clinical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Center for Pain Relief, St. Francis Hospital

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25301

Country

United States

Facility Name

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

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25702

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.nlm.nih.gov/medlineplus/chronicpain.html

Description

MedlinePlus related topics: Chronic pain

URL

http://clinicaltrials.gov/ct2/info/fdalinks

Description

US FDA Recourses

Learn more about this trial

Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

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