Clinical trial NCT01259271: Selective Nerve Stimulation (SNS) Pilot Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Pain
Keywords: human
nerve
modulation
Healthy human
sNCT
stimulation
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2010-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Modulation of Median Nerve Perception or Nerve Physiology
timeFrame: > 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Raynham
country: United States
facility: Codman & Shurtleff
state: Massachusetts
Study officials:
affiliation: Codman and Shurtleff
name: Sean Lilienfeld, MD
role: STUDY_CHAIR
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