Center for Neuroplasticity and Pain
Aalborg, Denmark
NCT Number: NCT06312254
The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.
The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aalborg, Denmark
Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room.
Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms.
In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%).
The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug is used to pharmacologically modulate peripheral sensory afferents
Drug is used to pharmacologically modulate peripheral sensory afferents
Drug is used to pharmacologically modulate peripheral sensory afferents
Drug is used as control
Time frame: 1 hour after application of cream
Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.
Aalborg University
Other
Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
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