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Electrical Stimulation
Group 1 (Treatment) for Neuropathic Pain (SNAP Trial)
N/A
Waitlist Available
Research Sponsored by SPR Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
SNAP Trial Summary
This trial will test whether electrical stimulation can relieve pain for people with an amputated leg.
Eligible Conditions
- Neuropathic Pain
- Amputation
SNAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Subjects That Experienced at Least One Study-Related Adverse Event
Number of Subjects With ≥50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])
Secondary outcome measures
Durability of Treatment Effect on Average Post-Amputation Pain Intensity (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])
Number of Subjects With ≥ 50% Reduction in Average Phantom Limb Pain (PLP) 5 to 8 Weeks After Start of Treatment
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
+6 moreSNAP Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group 1 (Treatment)Active Control1 Intervention
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.
Group II: Group 2 (Control)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
SPR Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
737 Total Patients Enrolled
Frequently Asked Questions
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