NCT06312254

Pharmacological Modulation of Peripheral Nerve Excitability

Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Topical lidocaine 5%	Drug is used to pharmacologically modulate peripheral sensory afferents
DRUG	Topical Phenytoin 10%	Drug is used to pharmacologically modulate peripheral sensory afferents
DRUG	Topical Mepyramine 2%	Drug is used to pharmacologically modulate peripheral sensory afferents
OTHER	Topical Placebo	Drug is used as control

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-12-02
• Completion: 2024-12-11
• First posted: 2024-03-15
• Last updated: 2025-04-30

Locations

1 site across 1 country: Denmark