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 ≥ 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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Signal more likely to block nerve |
Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block |
|
Active Comparator Signal less likely to block nerve |
Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block |
|
Recruiting Locations
Arizona Pain Institute
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Contact:
Shana Harshell, CRRC
Shana Harshell, CRRC
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Cindy Witkowski
Cindy Witkowski
UCLA Office of Clinical Research
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Adreanne Rivera, CRC
Adreanne Rivera, CRC
Nona Medical Arts
Orlando, Florida 32827
Orlando, Florida 32827
Contact:
Danielle Hague, CRC
Danielle Hague, CRC
Drug Studies America
Marietta, Georgia 30060
Marietta, Georgia 30060
Contact:
Patti Housley, CRC
Patti Housley, CRC
University of Illinois Chicago
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Mariela H. Girotti, RN
Mariela H. Girotti, RN
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Contact:
Jill Collins, CRC
Jill Collins, CRC
Henry Ford Health System
Detroit, Michigan 48202
Detroit, Michigan 48202
Contact:
Rehnuma Newaz, CRC
Rehnuma Newaz, CRC
Center for Clinical Research
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Contact:
Taunya M. Davis, CRC
Taunya M. Davis, CRC
Cleveland Clinic Pain Management
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Contact:
Ogena Saied, MS
Ogena Saied, MS
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Contact:
Loren D. Meckley
Loren D. Meckley
Meta Medical Research Institute
Dayton, Ohio 45432
Dayton, Ohio 45432
Contact:
Dan Geyer, MPH, CCRP
Dan Geyer, MPH, CCRP
Kettering Medical Center
Springboro, Ohio 45066
Springboro, Ohio 45066
Contact:
Allison Streifthau, RN
Allison Streifthau, RN
Advanced Surgical and Research Solutions
Oklahoma City, Oklahoma 73134
Oklahoma City, Oklahoma 73134
Contact:
Bradley P. Hightower, CCRC
Bradley P. Hightower, CCRC
HCA Health Services of Tennessee - Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Logan Michl, CRC
Logan Michl, CRC
Baylor Scott and White Research Institute
Dallas, Texas 75201
Dallas, Texas 75201
Contact:
Mariana Hurutado, BSN, CMI
Mariana Hurutado, BSN, CMI
Baylor Scott and White - Temple Memorial Vascular Surgery
Temple, Texas 76508
Temple, Texas 76508
Contact:
Ian Sawicki
Ian Sawicki
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
Contact:
Jason Caucutt, MA, CRC
Jason Caucutt, MA, CRC
More Details
- NCT ID
- NCT02221934
- Status
- 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.