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Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

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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:
Information provided by (Responsible Party):
Bioness Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Chronic Pain
Interventions Device: StimRouter - active stimulation
Device: StimRouter - Control
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Stimulation Treatment Control
Hide Arm/Group Description Subjects implanted with the StimRouter lead and randomized to receive active stimulation. Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
Period Title: Overall Study
Started 45 49
Completed 41 44
Not Completed 4 5
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             1             0
not available at primary outcome visit             2             4
Arm/Group Title Active Stimulation Treatment Control Total
Hide Arm/Group Description Subjects implanted with the StimRouter lead and randomized to receive active stimulation. Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation. Total of all reporting groups
Overall Number of Baseline Participants 45 49 94
Hide Baseline Analysis Population Description
Adults having severe intractable chronic pain of peripheral nerve origin were enrolled and all were included in the 94 intent-to-treat analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 49 participants 94 participants
52.8  (10.0) 53.2  (12.1) 53.0  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 49 participants 94 participants
Female
25
  55.6%
30
  61.2%
55
  58.5%
Male
20
  44.4%
19
  38.8%
39
  41.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 49 participants 94 participants
45 49 94
1.Primary Outcome
Title Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%
Hide Description 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.
Time Frame Baseline and at 3-month follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population was analyzed.
Arm/Group Title StimRouter - Active Stimulation StimRouter - Control
Hide Arm/Group 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 - 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- 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
Overall Number of Participants Analyzed 45 49
Measure Type: Number
Unit of Measure: participants
17 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection StimRouter - Active Stimulation, StimRouter - Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).
Hide Description 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).
Time Frame at 3 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.
Arm/Group Title StimRouter - Active Stimulation StimRouter - Control
Hide Arm/Group 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 - 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- 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
Overall Number of Participants Analyzed 41 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.8  (1.5) 2.5  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection StimRouter - Active Stimulation, StimRouter - Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.
Hide Description 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.
Time Frame at baseline and 3 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were analyzed from both treatment arms.
Arm/Group Title StimRouter - Active Stimulation StimRouter - Control
Hide Arm/Group 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 - 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- 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
Overall Number of Participants Analyzed 41 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (2.3) -0.3  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection StimRouter - Active Stimulation, StimRouter - Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.
Arm/Group Title StimRouter - Active Stimulation StimRouter - Control
Hide Arm/Group 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 - 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- 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
Overall Number of Participants Analyzed 41 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.3  (2.9) 3.0  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection StimRouter - Active Stimulation, StimRouter - Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were reported throughout the one year study period.
Adverse Event Reporting Description No device related serious adverse events were reported.
 
Arm/Group Title StimRouter Active Stimulation StimRouter Control
Hide Arm/Group Description

The stimulation program settings for the active stimulation 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

The stimulation program settings for the control 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
All-Cause Mortality
StimRouter Active Stimulation StimRouter Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
StimRouter Active Stimulation StimRouter Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/45 (20.00%)      11/49 (22.45%)    
Cardiac disorders     
heart arrhythmia * [1]  1/45 (2.22%)  1 1/49 (2.04%)  1
Gastrointestinal disorders     
Digestive issues * [2]  0/45 (0.00%)  0 2/49 (4.08%)  2
Hepatobiliary disorders     
gall bladder * [3]  1/45 (2.22%)  1 2/49 (4.08%)  2
Infections and infestations     
dermatological issues * [4]  1/45 (2.22%)  1 2/49 (4.08%)  2
Metabolism and nutrition disorders     
Dehydration * [5]  0/45 (0.00%)  0 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders     
Bone fracture, instability, compromise * [6]  3/45 (6.67%)  5 3/49 (6.12%)  3
Renal and urinary disorders     
Kidney failure and bladder tumor * [1]  3/45 (6.67%)  4 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory issues * [7]  2/45 (4.44%)  2 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated to device
[2]
diverticulitis not device related
[3]
cholelithiasis and cholecystectomy not device related
[4]
unrelated abscess, cellulitis, infection,
[5]
unrelated dehydration
[6]
Knee replacement, rotator cuff repair, spine instability/leak, bone fracture all unrelated to device
[7]
unrelated to device: pneumonia, breathing problems
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
StimRouter Active Stimulation StimRouter Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/45 (42.22%)      16/49 (32.65%)    
Gastrointestinal disorders     
Gastrointestinal * [1]  3/45 (6.67%)  5 3/49 (6.12%)  5
General disorders     
headache *  2/45 (4.44%)  4 0/49 (0.00%)  0
Medicine wthdrawn in error *  1/45 (2.22%)  1 0/49 (0.00%)  0
Infections and infestations     
Infection * [2]  1/45 (2.22%)  1 2/49 (4.08%)  3
Injury, poisoning and procedural complications     
Fall/bruising * [3]  0/45 (0.00%)  0 2/49 (4.08%)  3
Metabolism and nutrition disorders     
Dehydration *  1/45 (2.22%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal * [4]  4/45 (8.89%)  6 7/49 (14.29%)  18
Psychiatric disorders     
Psychiatric * [5]  0/45 (0.00%)  1/49 (2.04%)  2
Renal and urinary disorders     
renal * [6]  3/45 (6.67%)  3 2/49 (4.08%)  2
Reproductive system and breast disorders     
Sexual dysfunction * [7]  1/45 (2.22%)  1 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory * [8]  2/45 (4.44%)  3 1/49 (2.04%)  2
Skin and subcutaneous tissue disorders     
Localized pain irritation to patch/wound site *  15/45 (33.33%)  33 16/49 (32.65%)  26
Lead exposure * [9]  1/45 (2.22%)  2 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
diarrhea, diverticulitis, nausea
[2]
sinusitis
[3]
Falling due to frailty
[4]
Joint spine issues
[5]
confusion, dementia
[6]
kidney stone, urinary tract infection, kidney function
[7]
Delayed ejaculation
[8]
flu, cough
[9]
lead implanted too superficially, skin scratched by patient until lead became exposed requiring repositioning of lead
The device was designed for treatment of mononeuritis excluding the face. For this reason, mononeuropathies of the face were excluded.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Charlene Myers, Contractor
Organization: Bioness
Phone: 9499101655
Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01592344     History of Changes
Other Study ID Numbers: CP-STMR11-001
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: January 16, 2016
Results First Posted: March 14, 2016
Last Update Posted: April 11, 2016