Selective Nerve Stimulation (SNS) Pilot Study (SNS)

October 15, 2019 updated by: Codman & Shurtleff

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single center, single blind, randomized, crossover design, sham controlled pilot study using Selective Nerve Stimulation (SNS) signal for nerve modulation with three amplitudes (supra-threshold,sub-threshold and sham)

The primary objective of this proof of concept study is to:

• Evaluate median nerve modulation with selective nerve stimulation amplitudes (supra-threshold, sub-threshold, and sham) by means of objective quantitative sensory tests (QST) and Sensory Nerve Conduction Threshold Tests (sNCTs) in healthy subjects.

The secondary objectives to be evaluated in this study are to:

  • Establish device safety profile
  • Evaluate patient reported sensory descriptions and perception during modulation

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Raynham, Massachusetts, United States, 02767
        • Codman & Shurtleff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must fulfill all of the following criteria:

  • 18 years of age or older
  • Ability to provide written informed consent for participation in this study
  • Ability to understand and willing to comply with all study-related procedures, such as questionnaires, diaries and follow-up visits for the study duration
  • Ability to not use analgesics throughout the duration of the study

Exclusion Criteria:

  • Chronic peripheral pain or diagnosed neuropathy of the median nerve or the cervical spine (C6-C8) as reported by the subject
  • Use of analgesics within 3 days prior to screening / baseline visit and if the subject is unable to refrain from using any analgesics throughout their study participation
  • Metal implants in the forearm
  • Previous nerve damage or bone injury that led to median nerve damage
  • Previous surgery for carpal tunnel release in the non-dominant study hand
  • Skin irritation or active infection at or near the electrode placement sites
  • Allodynia involving the patch application area
  • Known history of allergic reaction to the adhesive, hydrogel or any other component of the electrode or patch
  • Use of an investigational drug or device within 30 days prior to study enrollment.
  • Use of Cardiac pacemaker, implantable cardioverter-defibrillators (ICD's), or other electrostimulation device
  • Currently untreated abuse of drugs and/or alcohol
  • Psychological or medical condition that would make the study participant unadvisable
  • Uncontrolled seizures (averaging > 2 seizures/month)
  • Pregnant, or planning on becoming pregnant or breastfeeding during the study period
  • Co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements.
  • Any known inabilities to be evaluated instrumentally by quantitative sensory testing (QST) or sensory nerve conduction threshold tests (sNCTs) for a median nerve neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supra-threshold
Supra-threshold is defined as the nerve stimulation amplitude at which a subject can tolerate sensory responses (like tingling, tapping in the thumb, index or middle fingers) but will not cause pain or duress to the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers and they feel the paresthesia or tingling sensation.
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.
Other Names:
  • Transdermal Amplitude Modulated Signal nerve stimulation device (TAMS)
Experimental: Sub-threshold
Sub-threshold is defined as the nerve stimulation amplitude just below the sensory perception of the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers. Subjects do not feel the paresthesia or tingling sensation despite there being a signal transmitted..
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.
Other Names:
  • Transdermal Amplitude Modulated Signal nerve stimulation device (TAMS)
Sham Comparator: Sham Control
All subjects in the sham arm will go through the same process / experimental setup as in each of the active stimulation arms; however there will be no stimulation signal during the sham stimulation (output set and SNS box locked at 0 V). As this is the Sham control, there is no intervention but rather the intevention (TAMS device) setup (Tyco electrodes, wires and stimulator) are sent with the subject as if it were on (and just like Subthreshold arm the subjects cannot feel the stimulation). Audible alerts (to signify that the box is unplugged) will be disabled throughout the duration of the study. This sham arm will be used to assess the placebo effect caused by the stimulation and hence isolate the true effect of stimulation.
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.
Other Names:
  • Transdermal Amplitude Modulated Signal nerve stimulation device (TAMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modulation of Median Nerve Perception or Nerve Physiology
Time Frame: > 2 weeks

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).
> 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codman & Shurtleff

Investigators

  • Study Chair: Sean Lilienfeld, MD, Codman and Shurtleff

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NM-FSB-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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