- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02312752
Intra-epidermal Stimulation (IES) of Small Nerve Fibers (A-delta Fibers) (IES)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Individuals aged 21 through 60 years with no history or clinical signs of neuropathy.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility to selectively stimulate and record from A-delta nerve fibers using the intra-epidermal stimulation electrode as measured by electromyography (EMG)
Tidsram: one year
|
Stimulate and record from A-delta nerve fibers in normal individual using intra-epidermal stimulation electrode.
|
one year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David Walk, MD, University of Minnesota
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 140103
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