Pharmacological Modulation of Peripheral Nerve Excitability

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312254
• Other study ID #: N-20230071
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Aalborg University
• Contact: Trine Andresen, Post.Doc
• Phone: 004528908551
• Email: trinea[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Topical lidocaine 5%
Drug is used to pharmacologically modulate peripheral sensory afferents
• Topical Phenytoin 10%
Drug is used to pharmacologically modulate peripheral sensory afferents
• Topical Mepyramine 2%
Drug is used to pharmacologically modulate peripheral sensory afferents

Other:
• Topical Placebo
Drug is used as control

Locations

Country	Name	City	State
Denmark	Center for Neuroplasticity and Pain	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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