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NCT01259271 · ClinicalTrials.gov registry record · Early Phase 1
Selective Nerve Stimulation (SNS) Pilot Study
A Early Phase 1 study, sponsored by Codman & Shurtleff.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT01259271: Completed Early Phase 1 study, sponsored by Codman & Shurtleff.
NCT01259271 is a Early Phase 1 study that has completed, run by Codman & Shurtleff. The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259271, a Early Phase 1 study, has completed, sponsored by Codman & Shurtleff.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is right-handed the electrodes will be placed on the subject's left wrist) of the study subject. These patches will be connected by wires (leads) to a small box with a headphone jack. This is designed to provide gentle electrical stimulation through the skin. This study will look at the amount of change from normal nerve function, the sensory effects (feeling, sensations in the body), and any changes the subject has when performing the 2 hour tests. The safety of the study device will also be evaluated.
Primary Outcome
The primary effectiveness endpoints are the modulation of median nerve perception or nerve physiology as measured by: * QST evaluated by method of levels for vibratory perception threshold (VS) in ABeta fibers and for cold sensation threshold (CS) in alpha gamma fibers and warm sensation threshold (WS) in c fibers. * sNCTs Current Perception Threshold (CPT) in ABeta, Alpha gamma and c fibers (CPT2k, CPT250, CPT5 respectively).
Interventions
- DEVICE Selective Nerve Stimulation (SNS) stimulator device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2011-02-01 |
| Phase | Early Phase 1 |
What the finished NCT01259271 record still lists
NCT01259271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 1 intervention - of which Selective Nerve Stimulation (SNS) stimulator device is the first listed.
NCT01259271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01259271 about?
NCT01259271 is a clinical study titled "Selective Nerve Stimulation (SNS) Pilot Study". The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand ...
What is the current status of trial NCT01259271?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2010-11-01. Estimated completion is 2011-02-01.
What interventions are being tested in trial NCT01259271?
The interventions under investigation include: Selective Nerve Stimulation (SNS) stimulator device (DEVICE).
Who is sponsoring clinical trial NCT01259271?
This trial is sponsored by Codman & Shurtleff, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01259271's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,564 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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