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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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

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 more

SNAP 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.

Find a Location

Who is running the clinical trial?

SPR Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
737 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025