Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
NCT ID: NCT01996254
Last Updated: 2020-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2013-10-31
2019-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPRINT Group 1
Subjects in Group 1 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System is an Investigational Device which 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).
SPRINT Group 2
Subjects in Group 2 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System for a total of 8 weeks. They will receive 4 weeks of stimulation and 4 weeks with no stimulation.
SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System is an Investigational Device which 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).
Interventions
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SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System is an Investigational Device which 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Traumatic lower extremity amputation(s)
* Healed amputation and healthy residual limb based upon the investigator's evaluation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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NDI Medical, LLC
INDUSTRY
United States Department of Defense
FED
SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Josh Boggs, PhD
Role: PRINCIPAL_INVESTIGATOR
SPR Therapeutics, Inc.
Locations
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Arizona Pain
Scottsdale, Arizona, United States
University of California San Diego
La Jolla, California, United States
Denver Clinic for Extremities at Risk
Denver, Colorado, United States
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Northwestern University
Chicago, Illinois, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Countries
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References
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Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2019 Nov 17:rapm-2019-100937. doi: 10.1136/rapm-2019-100937. Online ahead of print.
Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sponsor's Website
Collaborator's Website
Other Identifiers
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0123-CSP-000
Identifier Type: -
Identifier Source: org_study_id
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