Electrical Nerve Block for Amputation Pain

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

  • Post-Amputation Pain
  • Phantom Limb Pain
  • Residual Limb Pain
  • Stump Pain

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 ≥ 4 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
Test Treatment 		Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
  • Device: Altius
    Electrical signal
Active Comparator
Active Sham Control Treatment 		Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
  • Device: Altius
    Electrical signal

Recruiting Locations

More Details

NCT ID
NCT02221934
Status
Active, not recruiting
Sponsor
Neuros Medical, Inc.

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.