Overview

This trial is active, not recruiting.

Condition healthy
Treatment intra-epidermal stimulation electrode
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date December 2014
End date December 2018
Trial size 3 participants
Trial identifier NCT02312752, 140103

Summary

The purpose of the study is to determine whether a particular type of nerve fibers, A-delta fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy volunteers will be enrolled in this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
A small piece of plastic with a tiny sharp protruding tip (the intra-epidermal stimulation electrode) will be applied to the foot and hand. Small "sticker" electrodes will be placed over nerves on the forearm or ankle. A stimulus will be applied to the electrode for intra-epidermal stimulation. The stimulus will be gradually increased from no stimulus to a stimulus that is barely felt as a pin-prick type of sensation. Thereafter, the stimulus will be applied 5-15 times per second for 10 periods of 40-60 seconds.
intra-epidermal stimulation electrode
A small piece of plastic with a tiny sharp protruding tip (the intra-epidermal stimulation electrode) will be applied to the foot and hand. Small "sticker" electrodes will be placed over nerves on the forearm or ankle. A stimulus will be applied to the electrode for intra-epidermal stimulation. The stimulus will be gradually increased from no stimulus to a stimulus that is barely felt as a pin-prick type of sensation. Thereafter, the stimulus will be applied 5-15 times per second for 10 periods of 40-60 seconds.

Primary Outcomes

Measure
Feasibility to selectively stimulate and record from A-delta nerve fibers using the intra-epidermal stimulation electrode as measured by electromyography (EMG)
time frame: one year

Eligibility Criteria

Male or female participants from 21 years up to 60 years old.

Inclusion Criteria: - Individuals aged 21 through 60 years with no history or clinical signs of neuropathy. Exclusion Criteria: 1. History of peripheral nerve disease or disease of somatosensory pathways. 2. Abnormalities on neurologic examination. 3. Prior or current exposure to known neurotoxins, such as excessive alcohol use or chemotherapy. 4. Neurologic or psychiatric conditions that would prevent the subject from being able to cooperate with testing.

Additional Information

Official title Intra-epidermal Stimulation (IES) of Small Nerve Fibers (A-delta Fibers)
Principal investigator David Walk, MD
Description The epidermis is the outermost layer of the skin that includes skin cells and small nerve fibers called A-delta fibers. A-delta fibers send signals to the brain about pin-prick type of pain and temperature. The investigators want to study whether the investigators can stimulate A-delta fibers and document this by recording electrical potentials from the nerves in subjects' limbs. Study Procedures: A small piece of plastic will be applied to your foot and your hand. A tiny sharp tip protrudes from this piece of plastic. You will be barely able to feel this sharp tip when touching the piece of plastic. This is the electrode for intra-epidermal stimulation. With stimulation, you will feel a pin-prick type of sensation. The stimulus will be adjusted so that you barely feel the pin-prick type of sensation. The investigators will record responses of stimulation from nerves in your skin.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.