Selective Nerve Stimulation (SNS) Pilot Study

Healthy Clinical Trial

— SNS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259271
• Other study ID #: NM-FSB-1001
• Status: Completed
• Phase: Early Phase 1
• Start date: November 1, 2010
• Est. completion date: February 1, 2011

Study information

• Verified date: October 2019
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2011
• Est. primary completion date: February 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Codman & Shurtleff	Raynham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulation of Median Nerve Perception or Nerve Physiology	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