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Electrical Nerve Block for Amputation Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Neuros Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Neuros Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02221934
First received: August 15, 2014
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
The purpose of the clinical trial is to learn whether electrical nerve block is a safe and effective treatment for patients with post-amputation pain.

Condition Intervention
Post-Amputation Pain
Phantom Limb Pain
Residual Limb Pain
Stump Pain
Device: Altius

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

Further study details as provided by Neuros Medical, Inc.:

Primary Outcome Measures:
  • Pain reduction after each treatment session as measured by Numerical Rating Scale [ Time Frame: 3 months post implant ]
  • Incidence of all serious adverse events [ Time Frame: 3 months post implant ]

Secondary Outcome Measures:
  • Pain Medication Use [ Time Frame: 12 months post implant ]
  • Pain interference to Activities of Daily Living (ADL) [ Time Frame: 12 months post implant ]
  • Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]

Estimated Enrollment: 130
Study Start Date: September 2014
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Signal more likely to block nerve
Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
Device: Altius
Electrical signal
Active Comparator: Signal less likely to block nerve
Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
Device: Altius
Electrical signal

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • One amputated lower limb
  • Frequent and recurring amputation pain
  • Residual limb pain and/or phantom limb pain

Key Exclusion Criteria:

  • Currently implanted with active medical device (e.g. pacemaker or drug pump)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02221934

Locations
United States, Ohio
Neuros Medical, Inc. Recruiting
Willoughby Hills, Ohio, United States, 44094
Contact: Clinical Trials       ClinicalTrials@neurosmedical.com   
Sponsors and Collaborators
Neuros Medical, Inc.
Investigators
Principal Investigator: Leonardo Kapural, MD, PhD Center for Clinical Research, Winston-Salem NC
  More Information

Responsible Party: Neuros Medical, Inc.
ClinicalTrials.gov Identifier: NCT02221934     History of Changes
Other Study ID Numbers: 003-0001 
Study First Received: August 15, 2014
Last Updated: September 30, 2016

Keywords provided by Neuros Medical, Inc.:
Pain
Chronic
Amputation
Phantom Pain
Stump Pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on February 24, 2017