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

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Device: Intra-epidermal stimulation electrode

• Registration Number: NCT02312752
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2014-11-12
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-epidermal stimulation	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 Outcome Measures

Name	Time	Method
Feasibility to selectively stimulate and record from A-delta nerve fibers using the intra-epidermal stimulation electrode as measured by electromyography (EMG)	one year	Stimulate and record from A-delta nerve fibers in normal individual using intra-epidermal stimulation electrode.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States