Pharmacological Modulation of Peripheral Nerve Excitability

NCT ID: NCT06312254

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2024-12-11

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.

Conditions

Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Pharmacological modulation with lidocaine 5%

Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated

Group Type: ACTIVE_COMPARATOR

Topical lidocaine 5%

Intervention Type: DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Pharmacological modulation with Phenytoin 10%

Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated

Group Type: ACTIVE_COMPARATOR

Topical Phenytoin 10%

Intervention Type: DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Pharmacological modulation with Mepyramine 2%

Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated

Group Type: ACTIVE_COMPARATOR

Topical Mepyramine 2%

Intervention Type: DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Control

Experimental investigation of pharmacological modulation of peripheral nerve excitability, which is measured with the human perception threshold tracking method. With this method neurophysiological mechanisms of sensory afferents can be investigated

Group Type: PLACEBO_COMPARATOR

Topical Placebo

Intervention Type: OTHER

Drug is used as control

Interventions

Topical lidocaine 5%

Drug is used to pharmacologically modulate peripheral sensory afferents

Intervention Type: DRUG

Topical Phenytoin 10%

Drug is used to pharmacologically modulate peripheral sensory afferents

Intervention Type: DRUG

Topical Mepyramine 2%

Drug is used to pharmacologically modulate peripheral sensory afferents

Intervention Type: DRUG

Topical Placebo

Drug is used as control

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Carsten Dahl Mørch

M.Sc., Ph.D., Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trine Andresen, Post.Doc

Role: STUDY_DIRECTOR

Center for Neuroplasticity and Pain

Locations

Center for Neuroplasticity and Pain

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20230071

Identifier Type: -

Identifier Source: org_study_id