CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 60 enrolled
Drug / intervention
Selective Nerve Stimulation (SNS) stimulator devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01259271
NCT01259271Early Ph 1Completed

Single Center, Single Blind, Randomized, Sham Controlled Pilot Study Using Selective Nerve Stimulation (SNS) Signal for Nerve Modulation With Three Amplitudes (Supra-threshold, Sub-threshold and Sham)

Codman & Shurtleff·interventional·Posted Dec 14, 2010·Updated Oct 18, 2019

In Brief

A Early Phase 1 clinical trial evaluating Selective Nerve Stimulation (SNS) stimulator device for Healthy and Pain. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Pain
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2010
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.5 years ago

Interventions

Selective Nerve Stimulation (SNS) stimulator devicedevice

Two hours per study visit separated by a minimum of a 20 hour wash out period between stimulations.