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
  Purpose
This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.

Condition Intervention Phase
Unilateral Carpal Tunnel Syndrome
Device: StimRouter System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves

Resource links provided by NLM:


Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • Implant Success [ Time Frame: at device implantation procedure ] [ Designated as safety issue: No ]
    Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.


Secondary Outcome Measures:
  • Patent Satisfaction [ Time Frame: Day 5 after final stimulation ] [ Designated as safety issue: No ]
    Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied

  • Percent of Participants Reporting Pain Change From Baseline to Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is 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' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.

  • Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5 [ Time Frame: Day 5 after final stimulation ] [ Designated as safety issue: No ]
    Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ''no pain'' and a 10 for ''pain as bad as you can imagine.'' At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15).


Enrollment: 10
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: StimRouter (SR) for CTS
Percutaneous implantation of StimRouter System
Device: StimRouter System
Implanted with StimRouter System receive 6 hours (or less if not tolerated by the Subject)of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)

Detailed Description:
This is a prospective, single-center, open label study designed to evaluate the clinical use of the StimRouter (STR) as a peripheral nerve stimulation device for the treatment of chronic pain. The clinical study is proposed to serve as an evaluation of the preliminary StimRouter design, proposed implantation techniques, electrical stimulation parameters, and outcome measures for the StimRouter. The current study will utilize the median nerve (in the context of carpal tunnel syndrome (CTS), status-post a single failed carpal tunnel release (CTR) surgery)as a model to represent the device's more general intended use as a peripheral nerve stimulator to treat chronic pain.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Chronic peripheral pain persisting for greater than or equal to 3 months diagnosed previously as a mononeuropathy of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
  • Average chronic pain level greater than or equal to 5/10 [on 0-10 numeric rating scale (NRS) (BPI#14)], where such pain is attributed to injury, irritation, or entrapment of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
  • Failure of a single prior carpal tunnel release surgery to provide relief, where such failed surgery was performed greater than or equal to study entry
  • Able to tolerate stimulation (TENS)
  • Temporary pain relief is achieved by local anesthetic block of the target median nerve suspected to be the source of chronic pain symptoms
  • Ability to give informed consent and understand study requirements
  • Ability to quantify pain using a 0-10 numeric rating scale [A screening tool will be used to ensure that subjects can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other, with mosquito bite < stubbed toe < broken bone]
  • Willing and able to understand and comply with all study-related procedures during the course of the study
  • Motivated to maintain an accurate diary for the study duration

Exclusion Criteria:

  • Metal implants in the forearm
  • Active infection
  • Active or existing skin disorder or irritation which, at the physician's discretion, contraindications use of skin gel electrodes
  • Allodynia
  • Regular use of antiplatelet medications [e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)]
  • Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
  • Cardiac pacemaker
  • Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve stimulator) or implanted pump or infusion device
  • History of cardiac arrhythmia with homodynamic instability
  • Untreated drug habituation or dependence
  • Psychologically or medically unstable
  • Uncontrolled seizures (averaging > 2 seizures per month)
  • Pregnant or plan on becoming pregnant or breastfeeding during the study period
  • Currently require, or likely to require, diathermy and/or MRI during the study duration
  • History of adverse reactions to local anesthetic (e.g., lidocaine)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665132

Locations
United States, West Virginia
The Center for Pain Relief
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Bioness Inc
Investigators
Study Director: Evan L. Rosenfeld, MD, JD Bioness Inc
  More Information

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

Keywords provided by Bioness Inc:
wrist
hand
pain
failed CTR
carpal tunnel syndrome
CTS
CTR
carpel tunnel release
Peripheral nerve
Median nerve

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on August 24, 2016