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NCT01996254 · ClinicalTrials.gov registry record · NA
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
A NA study, sponsored by SPR Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT01996254: Completed NA study, sponsored by SPR Therapeutics.
NCT01996254 is a NA study that has completed, run by SPR Therapeutics. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01996254, a NA study, has completed, sponsored by SPR Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Primary Outcome
Subjects completed daily diaries to record their average daily pain intensity scores for each qualifying region of pain (phantom limb pain and/or residual limb pain). These pain intensity questions were excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5). The BPI-5 is an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." Post-amputation pain intensity scores were determined for each subject by taking the mean of th
Interventions
- DEVICE SPRINT Peripheral Nerve Stimulation (PNS) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-10 |
| Est. Completion | 2019-01-28 |
| Phase | NA |
What the finished NCT01996254 record still lists
NCT01996254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which SPRINT Peripheral Nerve Stimulation (PNS) System is the first listed.
NCT01996254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01996254 about?
NCT01996254 is a clinical study titled "Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System". The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The ...
What is the current status of trial NCT01996254?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2013-10. Estimated completion is 2019-01-28.
What interventions are being tested in trial NCT01996254?
The interventions under investigation include: SPRINT Peripheral Nerve Stimulation (PNS) System (DEVICE).
Who is sponsoring clinical trial NCT01996254?
This trial is sponsored by SPR Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01996254's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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