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Completed

NCT Number: NCT06312254

Pharmacological Modulation of Peripheral Nerve Excitability

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neuroplasticity and Pain

Aalborg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and Women age > 18 years
  • Understand and speak Danish
  • No medication besides contraceptives

Exclusion criteria

  • Pregnancy or lactating women
  • Drug addiction (use of cannabis, opioids, or other drugs)
  • Use of pain killers, alcohol, or nicotine within the last 24 hours before study start
  • Any other medical treatment (e.g., antidepressants, anticonvulsants)
  • History of peripheral or chronic pain conditions / neuropathy
  • Skin diseases
  • Scars and/or tattoos at the volar site of the forearm
  • Previous traumatic experience of an electrical accident
  • Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
  • Participation in any other research projects/studies 7 days before study start
  • Known allergy/intolerance to lidocaine/phenytoin/mepyramine
  • Lack of ability to cooperate

Treatment and study plan

Topical lidocaine 5%

Drug

Drug is used to pharmacologically modulate peripheral sensory afferents

Topical Phenytoin 10%

Drug

Drug is used to pharmacologically modulate peripheral sensory afferents

Topical Mepyramine 2%

Drug

Drug is used to pharmacologically modulate peripheral sensory afferents

Topical Placebo

Other

Drug is used as control

Primary outcomes

  1. Change in PTT-value

    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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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