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Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

NCT01592344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-04-11

Study results available
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Summary

The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.

Conditions

Interventions

DEVICE

StimRouter - active stimulation

The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 100-250 µsec * Pulse Rate: 50-100 Hz * Intensity: 0-30mA Time Settings * Constant Stim: On * Total Time: 6 hour

DEVICE

StimRouter - Control

The stimulation program settings for this arm are as follows: Stim Settings * Waveform: Symmetric or Asymmetric * Phase Duration: 200 µsec * Pulse Rate: 1 Hz * Intensity: 0 mA Time Settings * Constant Stim: On * Total Time: 6 hour

Sponsors & Collaborators

  • Bioness Inc

    lead INDUSTRY

Principal Investigators

  • Linh Nguyen, MS · Bioness Inc

  • Ramsin Benyamin, M.D. · Millennium Pain Center

  • Timothy Deer, M.D. · Center for Pain Relief, St. Francis Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-10-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592344 on ClinicalTrials.gov