Status:
ACTIVE_NOT_RECRUITING
Electrical Nerve Block for Amputation Pain
Lead Sponsor:
Neuros Medical, Inc.
Conditions:
Post-Amputation Pain
Phantom Limb Pain
Eligibility:
All Genders
21+ years
Phase:
NA
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.
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-dest...
Eligibility Criteria
Inclusion
- Key
- Age ≥ 21 years old
- Unilateral amputated leg ≥ 12 months
- Chronic post amputation pain ≥ 6 months
- Pain episodes typically lasting ≥ 60 minutes
- Stable drug regimen ≥ 4 weeks
- No changes to medications or prosthesis for 3-month primary study period
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT02221934
Start Date
October 9 2014
End Date
September 1 2025
Last Update
June 6 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Pain Institute
Scottsdale, Arizona, United States, 85258
2
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
3
HCA Healthcare Research Institute / St. Luke's Presbyterian
Denver, Colorado, United States, 80218
4
Nona Medical Arts
Orlando, Florida, United States, 32827