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

NCT03783689 | Terminated Results FDA Device

• 1 other identifier: 0147-CSP-000
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 14

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.

Conditions

Neuropathic Pain; Amputation

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With ≥50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])

  All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day period for each region of pain at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each subject's qualifying region of pain (residual limb and/or phantom limb pain with qualifying average pain intensity at baseline). To be considered a success, subjects must have experienced ≥ 50% reduction in all qualifying regions of pain compared to their 7-day baseline diary average pain score(s). The number of successes is presented.

  Baseline and 5 to 8 weeks post-start of treatment (SOT)

• Number of Subjects That Experienced at Least One Study-Related Adverse Event

  At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition have occurred since their previous visit. If the subject experienced a change that was a study-related adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.

  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 (9)

• Pain Interference

  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)

• Pain Disability Index (PDI)

  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)

• Patient Global Impression of Change (PGIC) Survey

  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)

• Pain Catastrophizing Scale (PCS)

  Visit 1 (Baseline), Visit 7 (4-weeks post-Start of Treatment [SOT]), and Visit 11 (8-weeks post-SOT)

• Pain Medication Usage

  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

Study Arms (2)

Group 1 (Treatment)

ACTIVE COMPARATOR

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

Group 2 (Control)

SHAM COMPARATOR

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

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) System DEVICE

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).

Also known as: SPRINT, SPRINT System

Group 1 (Treatment); Group 2 (Control)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• SPR Therapeutics, Inc.: lead

Study Sites (14)

Pain Center of Arizona - Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Lake Nona Medical Arts

Orlando, Florida, 32827, United States

Location

James A. Haley Veterans' Hospital

Tampa, Florida, 33612, United States

Location

Better Health Clinical Research

Newnan, Georgia, 30265, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

OtriMed Clinical Research Center

Edgewood, Kentucky, 41017, United States

Location

MedVadis Research

Waltham, Massachusetts, 02451, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Pain Management Center

Voorhees Township, New Jersey, 08043, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Affairs
• Organization: SPR Therapeutics, Inc

support@sprtherapeutics.com

216-378-9106

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: December 18, 2018
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Locations

US (14)