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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lidocaine 5% | Drug | Drug is used to pharmacologically modulate peripheral sensory afferents |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trine Andresen, Post.Doc | Center for Neuroplasticity and Pain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neuroplasticity and Pain | Aalborg | Denmark |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Participant and investigator/project involved personal is blinded to which cream is applied.
| Topical Phenytoin 10% | Drug | Drug is used to pharmacologically modulate peripheral sensory afferents |
|
| Topical Mepyramine 2% | Drug | Drug is used to pharmacologically modulate peripheral sensory afferents |
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| Topical Placebo | Other | Drug is used as control |
|