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Selective Nerve Stimulation (SNS) Pilot Study

NCT01259271 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-18

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Selective Nerve Stimulation (SNS) stimulator device

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

Sponsors & Collaborators

  • Codman & Shurtleff

    lead INDUSTRY

Principal Investigators

  • Sean Lilienfeld, MD · Codman and Shurtleff

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-01
Primary Completion
2011-02-01
Completion
2011-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259271 on ClinicalTrials.gov