Selective Nerve Stimulation (SNS) Pilot Study

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

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