Electrical Nerve Block for Amputation Pain



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:6/3/2018
Start Date:October 9, 2014
End Date:September 2025
Contact:Barbara S Lindsay
Email:blindsay@neurosmedical.com

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High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

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.

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.

Key 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

Key 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 expectance of less than 24 months

- Progressive neurological disease (i.e. multiple sclerosis)
We found this trial at
13
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Konstantin Slavin, MD
Phone: 312-996-2949
University of Illinois at Chicago A major research university in the heart of one of...
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Cleveland, Ohio 44195
Principal Investigator: Nagy Mekhail, MD
Phone: 216-445-8270
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Cleveland, OH
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Cleveland, Ohio 44106
Principal Investigator: Elias Veizi, MD
Phone: 216-791-3800
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Denver, Colorado 80218
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Little Rock, Arkansas 72205
Principal Investigator: Erika Petersen, MD
Phone: 501-526-5282
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Napa, California 94558
Principal Investigator: Eric Grigsby, MD
Phone: 707-252-9606
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Napa, CA
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New York, New York 10022
Principal Investigator: Cory Hunter, MD
Phone: 212-203-2813
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New York, NY
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Rancho Mirage, California 92270
Principal Investigator: Tobias Moeller-Bertram, MD
Phone: 760-994-7441
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Scottsdale, Arizona 85258
Principal Investigator: Tory McJunkin, MD
Phone: 480-245-6138
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Springboro, Ohio 45066
Principal Investigator: Vivek A. Manocha, MD
Phone: 937-395-8367
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245 Village Center Parkway
Stockbridge, Georgia 30281
Principal Investigator: Vincent Galan, MD
Phone: 770-771-6577
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Winston-Salem, North Carolina 27103
Principal Investigator: Leonardo Kapural, MD
Phone: 336-765-6181
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