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

Healthy Clinical Trial

— IES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02312752
• Other study ID #: 140103
• Status: Withdrawn
• Phase: N/A
• Start date: December 2014
• Est. completion date: June 2018

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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