Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
Overview
- Phase
- Not Applicable
- Intervention
- Topical lidocaine 5%
- Conditions
- Peripheral Neuropathy
- Sponsor
- Aalborg University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in PTT-value
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Carsten Dahl Mørch
M.Sc., Ph.D., Associate Professor
Aalborg University
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
Arms & Interventions
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
Intervention: Topical lidocaine 5%
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
Intervention: Topical Phenytoin 10%
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
Intervention: Topical Mepyramine 2%
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
Intervention: Topical Placebo
Outcomes
Primary Outcomes
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.