Status:
COMPLETED
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
Lead Sponsor:
Bioness Inc
Conditions:
Unilateral Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 cli...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00665132
Start Date
April 1 2008
End Date
December 1 2008
Last Update
June 6 2016
Active Locations (1)
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1
The Center for Pain Relief
Charleston, West Virginia, United States, 25301