Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain (SNAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783689
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

Brief Summary:
The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Amputation Device: SPRINT Peripheral Nerve Stimulation (PNS) System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain in a Randomized, Double-blinded, Placebo-controlled, Multicenter Trial
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Active Comparator: 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.
Device: 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 Names:
  • SPRINT
  • SPRINT System

Sham Comparator: 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.
Device: 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 Names:
  • SPRINT
  • SPRINT System




Primary Outcome Measures :
  1. Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP]) [ Time Frame: Baseline, 5-weeks post-Start of Therapy (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT ]
    Measured using question 5 from the Brief Pain Inventory- Short Form

  2. Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of Treatment ]
  3. Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]
  4. Study-Related Adverse Device Effects [ Time Frame: 1-week post-Start of Treatment ]
  5. Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of Treatment ]
  6. Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-Start of Treatment ]
  7. Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of Treatment ]
  8. Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-Start of Treatment ]
  9. Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-Start of Treatment ]
  10. Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-Start of Treatment ]
  11. Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of Treatment ]
  12. Study-Related Adverse Device Effects [ Time Frame: 1-week post-Lead removal ]
  13. Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of Treatment ]
  14. Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of Treatment ]
  15. Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of Treatment ]
  16. Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of Treatment ]
  17. Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment ]
  18. Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of optional Crossover Treatment ]
  19. Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of optional Crossover Treatment ]
  20. Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of optional Crossover Treatment ]
  21. Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of optional Crossover Treatment ]
  22. Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of optional Crossover Treatment ]
  23. Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of optional Crossover Treatment ]
  24. Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of optional Crossover Treatment ]

Secondary Outcome Measures :
  1. Pain Interference [ Time Frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT ]
    Measured using question 9 of the Brief Pain Inventory- Short Form

  2. Pain Disability [ Time Frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT ]
    Measured using the Pain Disability Index

  3. Patient Global Impression of Change (PGIC) [ Time Frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT ]
    Measured using the Patient Global Impression of Change PGIC survey

  4. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 4-weeks post-Start of Treatment (SOT), and 8-weeks post-SOT ]
    The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question are summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores are then calculated across all subjects.

  5. Pain Medication Usage [ Time Frame: Weeks 1-4 post-Start of Treatment (SOT), weeks 5-8 post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT ]
  6. Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP]) [ Time Frame: 1-week post-Start of Treatment (SOT), 2-weeks post-SOT, 3-weeks post-SOT, and 4-weeks post-SOT ]
  7. Proportion of subjects with ≥50% reduction in average Residual limb pain (RLP) [ Time Frame: 5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT ]
  8. Proportion of subjects with ≥50% reduction in average phantom limb pain (PLP) [ Time Frame: 5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT ]
  9. Durability of Treatment Effect on Average Pain Intensity [ Time Frame: 3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • At least 21 years old
  • Lower extremity amputation
  • Experiencing residual limb (stump) and/or phantom limb pain
  • Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

  • Conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections)
  • Implanted electronic device
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783689


Locations
Layout table for location information
United States, Arizona
Pain Center of Arizona - Hope Research Institute
Phoenix, Arizona, United States, 85018
United States, California
University of California San Diego
La Jolla, California, United States, 92093
United States, Florida
Lake Nona Medical Arts
Orlando, Florida, United States, 32827
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
United States, Georgia
Better Health Clinical Research
Newnan, Georgia, United States, 30265
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
Neuroscience Research Center, LLC
Overland Park, Kansas, United States, 66210
United States, Kentucky
OtriMed Clinical Research Center
Edgewood, Kentucky, United States, 41017
United States, Massachusetts
MedVadis Research
Waltham, Massachusetts, United States, 02451
United States, New Jersey
Premier Pain Centers
Shrewsbury, New Jersey, United States, 07702
Pain Management Center
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
SPR Therapeutics, Inc.
Layout table for additonal information
Responsible Party: SPR Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03783689    
Other Study ID Numbers: 0147-CSP-000
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations