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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Device: Intra-epidermal stimulation electrode

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: David Walk, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Intra-epidermal stimulation in healthy control subjects
• Other Study ID Numbers: 140103