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

NCT ID: NCT02312752

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intra-epidermal stimulation

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.

Group Type: OTHER

Intra-epidermal stimulation electrode

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Walk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

140103

Identifier Type: -

Identifier Source: org_study_id