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 Sex
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Test Treatment |
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius. |
|
|
Active Comparator Active Sham Control Treatment |
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius. |
|
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.