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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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Arizona Pain Institute
Scottsdale, Arizona 85258
Contact:
Shana Harshell, CRRC

University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas 72205
Contact:
Cindy Witkowski

UCLA Office of Clinical Research
Los Angeles, California 90095
Contact:
Amanda Gonzales, MPH, CCRP

Vitamed Research, LLC
Rancho Mirage, California 92270
Contact:
Chloe Grout-Hughes

Drug Studies America
Marietta, Georgia 30060
Contact:
Patti Housley, CRC

University of Illinois Chicago
Chicago, Illinois 60612
Contact:
Mariela H. Girotti, RN

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
Stephen Fletcher, CRC

Ainsworth Institute of Pain Management
New York, New York 10022
Contact:
Danny Cadet

Center for Clinical Research
Winston-Salem, North Carolina 27103
Contact:
Taunya M. Davis, CRC

Cleveland Clinic Pain Management
Cleveland, Ohio 44106
Contact:
Ogena Saied, MS

Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio 44106
Contact:
Loren D. Meckley

Kettering Medical Center
Springboro, Ohio 45066
Contact:
Allison Streifthau, RN

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Lauren Rejman, BS, CCRC

More Details

NCT ID
NCT02221934
Status
Recruiting
Sponsor
Neuros Medical, Inc.

Study Contact

Barbara S Lindsay
440-951-2565
blindsay@neurosmedical.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.