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Trial record 2 of 2 for:    neuros

Electrical Nerve Block for Amputation Pain

This study is currently recruiting participants.
Verified September 2017 by Neuros Medical, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02221934
First Posted: August 21, 2014
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Boston Biomedical Associates
Information provided by (Responsible Party):
Neuros Medical, Inc.
  Purpose
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System 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 (Participant, 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:
  • Primary Effectiveness [ Time Frame: 3 months post implant ]
    Demonstration of 50% reduction in a NRS pain score from pre-treatment to post-treatment for more than 50% of all pain episodes

  • Primary Safety [ Time Frame: 3 months post implant ]
    Incidence of all serious adverse events, including Serious Adverse Events, Serious Adverse Device Events, and Unanticipated (Serious) Adverse Device Events from the time of consent through 3 months post implant.


Secondary Outcome Measures:
  • Secondary Effectiveness: Pain Relief after 2 hours [ Time Frame: 12 months post implant ]
    Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment

  • Secondary Effectiveness: Pain Days per Week [ Time Frame: 12 months post implant ]
    Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.

  • Secondary Effectiveness: Pain Medication Use [ Time Frame: 12 months post implant ]
    Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.

  • Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL [ Time Frame: 12 months post implant ]
    Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.

  • Secondary Effectiveness: Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
    EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.

  • Secondary Effectiveness: Patient Global Impression of Change (PGIC) [ Time Frame: 12 months post implant ]
    Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits

  • Secondary Safety [ Time Frame: 12 months post implant ]
    Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.


Other Outcome Measures:
  • Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ]
    Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.


Estimated Enrollment: 130
Actual Study Start Date: October 9, 2014
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: December 2018 (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

Detailed Description:
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subject shall have a unilateral amputated lower limb for no less than 12 months.
  2. Post‐amputation pain shall be chronic (persistent over 6 months) and resistant to pain medications with a documented history within the subject's medical records.
  3. Subject shall have frequent and recurring pain defined as no less than 4 episodes of pain ≥ 5 (NRS) per week on average (to be confirmed with baseline pain diary).
  4. Subject's typical pain episode should last no less than 60 minutes.
  5. Subject shall demonstrate response to two injections, one regional nerve block and the other saline. Response to the regional nerve block is defined as greater than or equal to a 50% pain reduction by NRS after 15 minutes from administration of Lidocaine. An allowable, non‐therapeutic response to saline is defined as less than 30% pain reduction by NRS 15 minutes after administration. NRS must be ≥ 5 before first injection.
  6. Subject's regimen of drug therapy for pain shall be stable for no less than 6 weeks prior to implant and shall not change without approval of investigator. Subject shall sign a pain medication "contract" to confirm acceptance of guidelines for the use of pain medication.
  7. Subject agrees not to replace or alter their prosthetic (if applicable) until after their Month‐3 (primary endpoint) visit.
  8. Subject is able to independently read and complete all questionnaires provided in English and use electronic diary during study.
  9. Subject is willing and able to provide informed consent and comply with all procedures and assessments required by study protocol.
  10. Subject, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study, e.g., no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule.
  11. Subject shall be 21 years of age or older (FDA definition of nonpediatric) and legally able to provide written informed consent.

Exclusion Criteria:

  1. Subject is currently implanted with any active implantable device including but not limited to: pacemaker, implantable cardiac defibrillator, implantable neurostimulator, or implantable drug pump.
  2. Subject has a source of pain other than post‐amputation pain (incl. dysaesthesia, cancer‐related, visceral, angina, migraine, causalgia) which in the opinion of the investigator may interfere with the reporting of post‐amputation pain.
  3. Subject has medical contraindications to surgery, including but not limited to cardiovascular, pulmonary, renal, liver or hematological disorders, active inflammation, medical contraindication for general anesthesia (e.g., severe cardiopulmonary disease), high risk of infection due to comorbidity, compromised immune state (e.g., chemotherapy) or infectious etiology for amputation (e.g., osteomyelitis, cellulitis), or anticoagulant medication that cannot be discontinued for perioperative period.
  4. Uncontrolled diabetes as defined by HbA1c > 8.0.
  5. Spasticity in their residual limb such that the subject cannot achieve volitional full range of motion (ROM) of joints on involved side.
  6. Subject has skin graft or severe scarring over targeted implant site or any anatomical conditions that would prevent placement of the Altius System components.
  7. Subject demonstrates an inability to discern differences in pain severity, report pain intensity and related information, or complete a pain diary.
  8. Subject has a suspected or known allergy to any materials of the Altius System in tissue contact or Lidocaine (necessary for injection screen).
  9. Subject has received therapeutic regional nerve block (e.g. anesthetic with steroid, and/or opioids) for post‐amputation pain within 30 days prior to baseline visit.
  10. Subject's usual seated posture includes sitting on the end of their stump.
  11. Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding, or intends to become pregnant during the course of the study.
  12. Subject is currently participating or intends to participate in another investigational drug or device clinical study that may influence or interfere with the data that will be collected for this study.
  13. Subject has a condition requiring MRI studies or diathermy after device implantation.
  14. Subject has a history of any alcohol or substance abuse or dependence which has required prior medical treatment or intervention. Subject has active alcohol or substance abuse.
  15. Subject has a condition that, in the opinion of the investigator, would interfere with study compliance (incl. unresolved issues of secondary gain) or subject's safety.
  16. Subject has a life expectancy of less than 24 months.
  17. Subject is diagnosed with or has untreated psychological conditions:

    borderline personality disorder, major depression disorder, general anxiety disorder, or somatoform disorder.

  18. Subject has current diagnosis of any progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive diabetic peripheral neuropathy, or any tumor of the nervous system.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
Boston Biomedical Associates
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
First Submitted: August 15, 2014
First Posted: August 21, 2014
Last Update Posted: September 22, 2017
Last Verified: September 2017

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