The SNAP Trial: SPRINTĀ® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
Purpose
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
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections) - Implanted electronic device - Pregnancy
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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. |
|
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. |
|
More Details
- Status
- Terminated
- Sponsor
- SPR Therapeutics, Inc.