Clinical trial NCT03783689: The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
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
Overall status: TERMINATED
Phase: NA
Conditions: Neuropathic Pain
Amputation
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Subjects With ≥50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])
timeFrame: Baseline and 5 to 8 weeks post-start of treatment (SOT)
measure: Number of Subjects That Experienced at Least One Study-Related Adverse Event
timeFrame: Up to 14 months for each Group 1 subject and up to 18 months for each Group 2 subject (time from baseline to last study visit)
Secondary outcomes:
measure: Pain Interference
timeFrame: Visit 1 (Baseline), Visit 7 (4-weeks post-start of treatment [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT)
measure: Pain Disability Index (PDI)
timeFrame: Visit 1 (Baseline), Visit 7 (4-weeks post-start of treatment [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT)
measure: Patient Global Impression of Change (PGIC) Survey
timeFrame: Visit 7 (4-weeks post-Start of Therapy [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Visit 1 (Baseline), Visit 7 (4-weeks post-Start of Treatment [SOT]), and Visit 11 (8-weeks post-SOT)
measure: Pain Medication Usage
timeFrame: Baseline, 1 to 4 weeks post-start of treatment (SOT), 5 to 8 weeks post-SOT, 3 months post-SOT, 6 months post-SOT, and 12 months post-SOT
measure: Number of Subjects With ≥ 50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP]) 1 to 4 Weeks After Start of Treatment
timeFrame: Baseline and 1 to 4 weeks post-start of treatment (SOT)
measure: Number of Subjects With ≥ 50% Reduction in Average Residual Limb Pain (RLP) 5 to 8 Weeks After Start of Treatment
timeFrame: Baseline and 5 to 8 weeks post-start of treatment (SOT)
measure: Number of Subjects With ≥ 50% Reduction in Average Phantom Limb Pain (PLP) 5 to 8 Weeks After Start of Treatment
timeFrame: Baseline and 5 to 8 weeks post-start of treatment (SOT)
measure: Durability of Treatment Effect on Average Post-Amputation Pain Intensity (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])
timeFrame: Baseline, 3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pain Center of Arizona - Hope Research Institute
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Orlando
country: United States
facility: Lake Nona Medical Arts
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: Edgewood
country: United States
facility: OtriMed Clinical Research Center
state: Kentucky
city: Waltham
country: United States
facility: MedVadis Research
state: Massachusetts
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: Voorhees
country: United States
facility: Pain Management Center
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References: