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

Primary Purpose

Unilateral Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
StimRouter System
Sponsored by
Bioness Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Carpal Tunnel Syndrome focused on measuring wrist, hand, pain, failed CTR, carpal tunnel syndrome, CTS, CTR, carpel tunnel release, Peripheral nerve, Median nerve

Eligibility Criteria

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

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)

Sites / Locations

  • The Center for Pain Relief

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StimRouter (SR) for CTS

Arm Description

Percutaneous implantation of StimRouter System

Outcomes

Primary Outcome Measures

Implant Success
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
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
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
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).

Full Information

First Posted
April 21, 2008
Last Updated
May 1, 2016
Sponsor
Bioness Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00665132
Brief Title
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
Acronym
StimRouter
Official Title
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioness Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Carpal Tunnel Syndrome
Keywords
wrist, hand, pain, failed CTR, carpal tunnel syndrome, CTS, CTR, carpel tunnel release, Peripheral nerve, Median nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
StimRouter (SR) for CTS
Arm Type
Experimental
Arm Description
Percutaneous implantation of StimRouter System
Intervention Type
Device
Intervention Name(s)
StimRouter System
Intervention Description
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)
Primary Outcome Measure Information:
Title
Implant Success
Description
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.
Time Frame
at device implantation procedure
Secondary Outcome Measure Information:
Title
Patent Satisfaction
Description
Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied
Time Frame
Day 5 after final stimulation
Title
Percent of Participants Reporting Pain Change From Baseline to Day 5
Description
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.
Time Frame
Day 5
Title
Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5
Description
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).
Time Frame
Day 5 after final stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan L. Rosenfeld, MD, JD
Organizational Affiliation
Bioness Inc
Official's Role
Study Director
Facility Information:
Facility Name
The Center for Pain Relief
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15100589
Citation
Eisenberg E, Waisbrod H, Gerbershagen HU. Long-term peripheral nerve stimulation for painful nerve injuries. Clin J Pain. 2004 May-Jun;20(3):143-6. doi: 10.1097/00002508-200405000-00003.
Results Reference
background
PubMed Identifier
10998746
Citation
Day M. Neuromodulation: spinal cord and peripheral nerve stimulation. Curr Rev Pain. 2000;4(5):374-82. doi: 10.1007/s11916-000-0021-7.
Results Reference
background

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

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