Pharmacological Modulation of Peripheral Nerve Excitability

NCT06312254 | Completed

• 1 other identifier: N-20230071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Neuropathy

Keywords

Topical treatment; Small fiber excitability; Perception Threshold Tracking Method

Outcome Measures

Primary Outcomes (1)

• Change in PTT-value

  Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs.

  1 hour after application of cream

Study Arms (4)

Pharmacological modulation with lidocaine 5%

ACTIVE COMPARATOR

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

Drug: Topical lidocaine 5%

Pharmacological modulation with Phenytoin 10%

ACTIVE COMPARATOR

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

Drug: Topical Phenytoin 10%

Pharmacological modulation with Mepyramine 2%

ACTIVE COMPARATOR

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

Drug: Topical Mepyramine 2%

Control

PLACEBO COMPARATOR

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

Other: Topical Placebo

Interventions

Topical lidocaine 5% DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Pharmacological modulation with lidocaine 5%

Topical Phenytoin 10% DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Pharmacological modulation with Phenytoin 10%

Topical Mepyramine 2% DRUG

Drug is used to pharmacologically modulate peripheral sensory afferents

Pharmacological modulation with Mepyramine 2%

Topical Placebo OTHER

Drug is used as control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center for Neuroplasticity and Pain

Aalborg, Denmark

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Trine Andresen, Post.Doc

  Center for Neuroplasticity and Pain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and investigator/project involved personal is blinded to which cream is applied.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc., Ph.D., Associate Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: April 9, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 11, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

DK (1)