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

NCT00665132 | Completed Phase 1 Results

• 1 other identifier: CP-STMR07-001-Rev A.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Carpal Tunnel Syndrome

Keywords

wrist; hand; pain; failed CTR; carpal tunnel syndrome; CTS; CTR; carpel tunnel release; Peripheral nerve; Median nerve

Outcome Measures

Primary Outcomes (1)

• 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.

  at device implantation procedure

Secondary Outcomes (3)

• Patent Satisfaction

  Day 5 after final stimulation

• Percent of Participants Reporting Pain Change From Baseline to Day 5

  Day 5

• Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5

  Day 5 after final stimulation

Study Arms (1)

StimRouter (SR) for CTS

EXPERIMENTAL

Percutaneous implantation of StimRouter System

Device: StimRouter System

Interventions

StimRouter System DEVICE

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)

StimRouter (SR) for CTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (1)

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

Related Publications (2)

• 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.

  PMID: 15100589 BACKGROUND

• Day M. Neuromodulation: spinal cord and peripheral nerve stimulation. Curr Rev Pain. 2000;4(5):374-82. doi: 10.1007/s11916-000-0021-7.

  PMID: 10998746 BACKGROUND

MeSH Terms

Conditions

Pain; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Keith McBride, CTO
• Organization: Bioness

Keith.McBride@bioness.com

661-362-4866

Study Officials

• Evan L. Rosenfeld, MD, JD

  Bioness Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-05

Locations

US (1)