Selective Nerve Stimulation (SNS) Pilot Study

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy, Pain

In brief

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.

Key facts

Study ID

NCT01259271

Run by

Codman & Shurtleff

People needed

60

Starts

2010-11-01

Expected to finish

2011-02-01

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Codman & Shurtleff — Raynham, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.