The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
NCT ID: NCT03783689
Last Updated: 2023-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2018-12-18
2022-09-22
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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Group 1 (Treatment)
Subjects in Group 1 will have Leads 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 delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Group 2 (Control)
Subjects in Group 2 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Subjects will then have the option to crossover and receive stimulation therapy.
SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called "Leads") that are 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 delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called "Leads") that are 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
* Lower extremity amputation
* Experiencing residual limb (stump) and/or phantom limb pain
* Healed amputation and healthy residual limb based upon the investigator's evaluation
Exclusion Criteria
* Implanted electronic device
* Pregnancy
21 Years
ALL
No
Sponsors
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SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Pain Center of Arizona - Hope Research Institute
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
Lake Nona Medical Arts
Orlando, Florida, United States
James A. Haley Veterans' Hospital
Tampa, Florida, United States
Better Health Clinical Research
Newnan, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
OtriMed Clinical Research Center
Edgewood, Kentucky, United States
MedVadis Research
Waltham, Massachusetts, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Pain Management Center
Voorhees Township, New Jersey, United States
Duke University
Durham, North Carolina, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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0147-CSP-000
Identifier Type: -
Identifier Source: org_study_id