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Clinical Trials/NCT02312752
NCT02312752
Withdrawn
Not Applicable

Intra-epidermal Stimulation (IES) of Small Nerve Fibers (A-delta Fibers)

University of Minnesota1 site in 1 countryDecember 2014
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Minnesota
Locations
1
Primary Endpoint
Feasibility to selectively stimulate and record from A-delta nerve fibers using the intra-epidermal stimulation electrode as measured by electromyography (EMG)
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Individuals aged 21 through 60 years with no history or clinical signs of neuropathy.

Exclusion Criteria

  • History of peripheral nerve disease or disease of somatosensory pathways.
  • Abnormalities on neurologic examination.
  • Prior or current exposure to known neurotoxins, such as excessive alcohol use or chemotherapy.
  • Neurologic or psychiatric conditions that would prevent the subject from being able to cooperate with testing.

Outcomes

Primary Outcomes

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

Stimulate and record from A-delta nerve fibers in normal individual using intra-epidermal stimulation electrode.

Study Sites (1)

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