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

Primary Purpose

Neuropathic Pain, Amputation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPRINT Peripheral Nerve Stimulation (PNS) System
Sponsored by
SPR Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Center of Arizona - Hope Research Institute
  • University of California San Diego
  • Lake Nona Medical Arts
  • James A. Haley Veterans' Hospital
  • Better Health Clinical Research
  • Northwestern University
  • Neuroscience Research Center, LLC
  • OtriMed Clinical Research Center
  • MedVadis Research
  • Premier Pain Centers
  • Pain Management Center
  • Duke University
  • Center for Clinical Research
  • The University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1 (Treatment)

Group 2 (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])
Measured using question 5 from the Brief Pain Inventory- Short Form
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects
Study-Related Adverse Device Effects

Secondary Outcome Measures

Pain Interference
Measured using question 9 of the Brief Pain Inventory- Short Form
Pain Disability
Measured using the Pain Disability Index
Patient Global Impression of Change (PGIC)
Measured using the Patient Global Impression of Change PGIC survey
Pain Catastrophizing Scale (PCS)
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
Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])
Proportion of subjects with ≥50% reduction in average Residual limb pain (RLP)
Proportion of subjects with ≥50% reduction in average phantom limb pain (PLP)
Durability of Treatment Effect on Average Pain Intensity

Full Information

First Posted
December 19, 2018
Last Updated
October 19, 2022
Sponsor
SPR Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03783689
Brief Title
The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
Acronym
SNAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPR Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Treatment)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 (Control)
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
SPRINT Peripheral Nerve Stimulation (PNS) System
Other Intervention Name(s)
SPRINT, SPRINT System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])
Description
Measured using question 5 from the Brief Pain Inventory- Short Form
Time Frame
Baseline, 5-weeks post-Start of Therapy (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT
Title
Study-Related Adverse Device Effects
Time Frame
During Lead placement at Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
24-48 hours post-Lead placement
Title
Study-Related Adverse Device Effects
Time Frame
1-week post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
2-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
3-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
4-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
5-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
6-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
7-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
8-weeks post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
1-week post-Lead removal
Title
Study-Related Adverse Device Effects
Time Frame
3-months post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
6-months post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
9-months post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
12-months post-Start of Treatment
Title
Study-Related Adverse Device Effects
Time Frame
During Lead placement at Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
2-weeks post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
4-weeks post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
8-weeks post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
3-months post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
6-months post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
9-months post-Start of optional Crossover Treatment
Title
Study-Related Adverse Device Effects
Time Frame
12-months post-Start of optional Crossover Treatment
Secondary Outcome Measure Information:
Title
Pain Interference
Description
Measured using question 9 of the Brief Pain Inventory- Short Form
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
Title
Pain Disability
Description
Measured using the Pain Disability Index
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
Title
Patient Global Impression of Change (PGIC)
Description
Measured using the Patient Global Impression of Change PGIC survey
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
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 4-weeks post-Start of Treatment (SOT), and 8-weeks post-SOT
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pain Center of Arizona - Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Lake Nona Medical Arts
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
James A. Haley Veterans' Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Better Health Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Neuroscience Research Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
OtriMed Clinical Research Center
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
MedVadis Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Premier Pain Centers
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
Pain Management Center
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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