Study Stopped
Electrodes required gas sterilization before re-use which was not feasible
Intra-epidermal Stimulation (IES) of Small Nerve Fibers (A-delta Fibers)
IES
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2014
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 21, 2019
May 1, 2019
3.5 years
November 12, 2014
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Intra-epidermal stimulation
OTHERA 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
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.
Eligibility Criteria
You may qualify if:
- Individuals aged 21 through 60 years with no history or clinical signs of neuropathy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
David Walk, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2014
First Posted
December 9, 2014
Study Start
December 1, 2014
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
May 21, 2019
Record last verified: 2019-05