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Electrical Nerve Block for Amputation Pain

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.
 
ClinicalTrials.gov Identifier: NCT02221934
Recruitment Status : Recruiting
First Posted : August 21, 2014
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Neuros Medical, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Amputation Pain Phantom Limb Pain Residual Limb Pain Stump Pain Device: Altius Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
Actual Study Start Date : October 9, 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2025

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint: Reduction of Pain Level by 50% from Baseline [ Time Frame: 3 months post implant ]
    Demonstration of 50% reduction in a Numerical Rating Scale (NRS) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).

  2. Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events [ Time Frame: From consent through 3 months post implant ]
    Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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:
  1. 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.



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.


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

Key Inclusion Criteria:

  • Age ≥ 21 years old
  • Unilateral amputated leg ≥ 12 months
  • Chronic post amputation pain ≥ 6 months
  • Pain episodes typically lasting ≥ 60 minutes
  • Stable drug regimen ≥ 6 weeks
  • No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

  • Implanted with an active implantable medical device (i.e. pacemaker)
  • Confounding source of pain that interferes with reporting of limb pain
  • Uncontrolled diabetes
  • Spasticity preventing full range of motion of involved side
  • Extremely short stump; sits on end
  • Untreated psychological condition (i.e. borderline personality)
  • Condition requiring MRI studies or diathermy after device implant
  • Life expectancy of less than 24 months
  • Progressive neurological disease (i.e. multiple sclerosis)
  • Subjects with active local or systemic infection or immunocompromised

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


Contacts
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Contact: Barbara S Lindsay 440-951-2565 ext 126 blindsay@neurosmedical.com
Contact: Gita Ghadimi 440-951-2565 ext 180 gghadimi@neurosmedical.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Neuros Medical, Inc.
Investigators
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Principal Investigator: Leonardo Kapural, MD, PhD Center for Clinical Research, Winston-Salem NC
Additional Information:
Publications:
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Responsible Party: Neuros Medical, Inc.
ClinicalTrials.gov Identifier: NCT02221934    
Other Study ID Numbers: 003-0001
QUEST Trial ( Other Identifier: Neuros Medical )
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by Neuros Medical, Inc.:
Pain
Chronic
Amputation
Phantom Pain
Stump Pain
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain