Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312254
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-27
Brief Title:
Pharmacological Modulation of Peripheral Nerve Excitability
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
Pharmacological Modulation of Peripheral Nerve Excitability - Measurement With the Human Perception Threshold Tracking Method
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10mepyramine 2 and placebo
The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs lidocaine 5 phenytoin 10mepyramine 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None