Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | October 2013 |
| End Date: | January 28, 2019 |
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain
The purpose of this study is to determine if electrical stimulation (small levels of
electricity) can safely and effectively reduce post-amputation pain. This study involves a
device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to
nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that
is placed through the skin in the upper leg. It also includes a device worn on the body that
delivers stimulation (called the SPRINT Stimulator).
electricity) can safely and effectively reduce post-amputation pain. This study involves a
device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to
nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that
is placed through the skin in the upper leg. It also includes a device worn on the body that
delivers stimulation (called the SPRINT Stimulator).
Key Inclusion Criteria:
- At least 18 years old
- Traumatic lower extremity amputation(s)
- Healed amputation and healthy residual limb based upon the investigator's evaluation
Key Exclusion Criteria:
- Change of prescribed medications affecting pain within the past 4 weeks
- Compromised immune system based on medical history
- Implanted electronic device
- Bleeding disorder
- History of valvular heart disease
- Confounding central nervous system injuries and disorders
- History of recurrent skin infections
We found this trial at
10
sites
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Joshua Rosenow, MD
Phone: 312-695-0482
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Paul W Wu, MD
Phone: 954-229-7965
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Richard Liu, MD
Phone: 301-295-4455
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Denver, Colorado 80218
Principal Investigator: Giancarlo Barolat, MD
Phone: 303-928-8855
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Brian M Ilfeld, MD, MS
Phone: 858-657-1279
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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New York, New York 10022
Principal Investigator: Cory Hunter, MD
Phone: 212-203-2813
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Scottsdale, Arizona 85258
Principal Investigator: Tory McJunkin, MD
Phone: 480-245-6138
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Shrewsbury, New Jersey 07702
Principal Investigator: Sean Li, MD
Phone: 732-930-2423
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Washington, District of Columbia 20037
Principal Investigator: Mehul Desai, MD, MPH
Phone: 202-808-8295
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Winston-Salem, North Carolina 27103
Principal Investigator: Richard Rauck, MD
Phone: 336-765-6181
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