Clinical trial NCT06312254: Pharmacological Modulation of Peripheral Nerve Excitability
Official title: Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: Topical treatment
Small fiber excitability
Perception Threshold Tracking Method
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PTT-value
timeFrame: 1 hour after application of cream
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for Neuroplasticity and Pain
Study officials:
affiliation: Center for Neuroplasticity and Pain
name: Trine Andresen, Post.Doc
role: STUDY_DIRECTOR
References: