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.

Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date October 12, 2021
Actual Study Start Date  ICMJE December 18, 2018
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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
  • Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]
  • Study-Related Adverse Device Effects [ Time Frame: 1-week post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 1-week post-Lead removal ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of optional Crossover Treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Percent Change in Average Residual Limb Pain (RLP) and Phantom Limb Pain (PLP) Intensity [ 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
  • Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]
  • Study-Related Adverse Device Effects [ Time Frame: 1-week post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 1-week post-Lead removal ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 3-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 6-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 9-months post-Start of optional Crossover Treatment ]
  • Study-Related Adverse Device Effects [ Time Frame: 12-months post-Start of optional Crossover Treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • 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
  • 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
  • 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
  • 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.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Change in 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
  • Change in 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
  • Patient Global Impression of Change Score [ 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
  • Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 4-weeks post-Start of Treatment (SOT), and 8-weeks post-SOT ]
    Measured using the PCS questionnaire
  • 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 ]
  • Proportion of Successes in Group 1 (Treatment) Compared to Group 2 (Control) for Weeks 1-4 after the Start of Therapy (SOT) [ Time Frame: 1-week post-Start of Treatment (SOT), 2-weeks post-SOT, 3-weeks post-SOT, and 4-weeks post-SOT ]
  • Proportion of Successes in Group 1 (Treatment) Compared to Group 2 (Control) for Weeks 5-8 after the Start of Therapy (SOT) [ Time Frame: 5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT ]
    Residual limb pain (RLP) and phantom limb pain (PLP) analyzed separately
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
Official Title  ICMJE The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain in a Randomized, Double-blinded, Placebo-controlled, Multicenter Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Amputation
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: SPRINT Peripheral Nerve Stimulation (PNS) 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.
    Intervention: Device: SPRINT Peripheral Nerve Stimulation (PNS) System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783689
Other Study ID Numbers  ICMJE 0147-CSP-000
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SPR Therapeutics, Inc.
Study Sponsor  ICMJE SPR Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SPR Therapeutics, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP