Unilateral Carpal Tunnel Syndrome Clinical Trial
— StimRouterOfficial title:
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
| Verified date | August 2015 |
| Source | Bioness Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study is being done to see how well a new investigational medical device, the StimRouter 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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | The Center for Pain Relief | Charleston | West Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Bioness Inc |
United States,
Day M. Neuromodulation: spinal cord and peripheral nerve stimulation. Curr Rev Pain. 2000;4(5):374-82. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the clinical use of the StimRouter, an implanted peripheral nerve stimulator system, for treating chronic peripheral pain using the median nerve as a general mode for that overall intended use. | Throughout the study | No | |
| Secondary | To provide a preliminary evaluation of the outcome measurements that maybe used to assess the clinical benefits related to the use of the StimRouter System as a peripheral nerve stimulator to treat chronic, intractable pain. | Throughout the study | Yes |