Pharmacological Modulation of Peripheral Nerve Excitability

March 13, 2024 updated by: Carsten Dahl Mørch, Aalborg University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Center for Neuroplasticity and Pain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Topical lidocaine 5%
Drug is used to pharmacologically modulate peripheral sensory afferents
Active Comparator: 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
Drug: Topical Phenytoin 10%
Drug is used to pharmacologically modulate peripheral sensory afferents
Active Comparator: 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
Drug: Topical Mepyramine 2%
Drug is used to pharmacologically modulate peripheral sensory afferents
Placebo Comparator: 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
Other: Topical Placebo
Drug is used as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour after application of cream

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Investigators

  • Study Director: Trine Andresen, Post.Doc, Center for Neuroplasticity and Pain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20230071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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