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Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves (StimRouter)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT00665132
First received: April 21, 2008
Last updated: May 1, 2016
Last verified: May 2016
Results First Received: February 2, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unilateral Carpal Tunnel Syndrome
Intervention: Device: StimRouter System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
StimRouter Stimulation

Percutaneous implantation of StimRouter System

StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming).


Participant Flow:   Overall Study
    StimRouter Stimulation
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
  1. >/=18 years of age
  2. Carpal Tunnel chronic peripheral pain >/=3 mo with mean pain >/=5/10
  3. Failed prior carpal tunnel release surgery >/=3 mo
  4. Tolerates transcutaneous electrical nerve stimulation (TENS)

6. Pain relief by local anesthetic block of target nerve 7. Give informed consent 8. Quantify pain using 0 to 10 NRS


Reporting Groups
  Description
StimRouter (SR) Active Stimulation

Percutaneous implantation of StimRouter System

StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming).


Baseline Measures
   StimRouter (SR) Active Stimulation 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (7.7) 
Gender 
[Units: Participants]
 
Female   4 
Male   6 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   9 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Average pain level [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.7  (1.6) 
[1] Brief Pain Inventory (BPI) is an 11-point numerical rating scale (NRS) used to rate pain intensity, where zero (0) indicates ‘‘no pain’’ and 10 indicates ‘‘pain as bad as you can imagine.’’ At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (mean score).


  Outcome Measures
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1.  Primary:   Implant Success   [ Time Frame: at device implantation procedure ]

2.  Secondary:   Patent Satisfaction   [ Time Frame: Day 5 after final stimulation ]

3.  Secondary:   Percent of Participants Reporting Pain Change From Baseline to Day 5   [ Time Frame: Day 5 ]

4.  Secondary:   Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5   [ Time Frame: Day 5 after final stimulation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Keith McBride, CTO
Organization: Bioness
phone: 661-362-4866
e-mail: Keith.McBride@bioness.com


Publications:

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT00665132     History of Changes
Other Study ID Numbers: CP-STMR07-001-Rev A.1
Study First Received: April 21, 2008
Results First Received: February 2, 2016
Last Updated: May 1, 2016
Health Authority: United States: Institutional Review Board