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The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.
Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.
Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").
Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.
The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylocaine spray 100mg/ml | Active Comparator | Topical application |
|
| Ethanol | Placebo Comparator | Topical application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine spray 100mg/ml | Diagnostic Test | Topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Paradoxical heat sensation (PHS) | Number of PHS responders on arm treated with lidocaine 45 minutes after drug application and Number of PHS responders on arm treated with ethanol 45 minutes after drug application | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal Grill (TG) | Number of TG responders on arm treated with lidocaine 75 minutes after drug application and Number of TG responders on arm treated with ethanol 75 minutes after drug application | 75 minutes |
| Quality of the Thermal Grill (TG) |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal thresholds | Detection- and pain thresholds for cold, warm (degrees) stimuli at baseline without any treatment Detection- and pain thresholds for cold, warm (degrees) stimuli on arm treated with lidocaine 45 minutes after drug application Detection- and pain thresholds for cold, warm (degrees) stimuli on arm treated with ethanol 45 minutes after drug application | 45 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen L Schaldemose, MD | Contact | +45 93501942 | ells@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ellen L Schaldemose, MD | Danish Pain Research Center, Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Pain Research Center, Aarhus University, Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2022 | |
| Reset | Aug 17, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2021 | Apr 20, 2021 | SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2022 | Aug 17, 2023 |
| ID | Term |
|---|---|
| D009443 | Neuritis |
| D006987 | Hypesthesia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020886 | Somatosensory Disorders |
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| Ethanol |
| Diagnostic Test |
Topical application |
|
The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 75 minutes after drug application The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold) or only warm or only cold on arm treated with ethanol 75 minutes after drug application
| 75 minutes |
| Pain intensity of the Thermal Grill (TG) | The participants are asked to rate the intensity of pain on a visual analog scale (VAS) 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 90 minutes after drug application The participants are asked to rate the intensity of pain on a VAS 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 90 minutes after drug application | 90 minutes |
| Intensity of unpleasantness of the Thermal Grill (TG) | The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application | 95 minutes |
| Intensity of cold of the Thermal Grill (TG) | The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application | 95 minutes |
| Intensity of warm of the Thermal Grill (TG) | The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application | 95 minutes |
| Paradoxical heat sensation (PHS) | Number of PHS responders at baseline without any treatment, 30 minutes before drug application | 30 minutes before drug application |
| Thermal Grill (TG) | Number of TG responders at baseline without any treatment 20 minutes before drug application | 20 minutes before drug application |
| Paradoxical heat sensation (PHS) using a modified protocol | Number of PHS responders if the skin is heated or cooled prior the test at baseline without any treatment Number of PHS responders if the skin is heated or cooled prior the test on arm treated with lidocaine 100 minutes after drug application Number of PHS responders if the skin is heated or cooled prior the test on arm treated with ethanol 100 minutes after drug application | 100 minutes |
| Mechanical thresholds | Detection- and pain thresholds for mechanical (mNewton) stimuli at baseline without any treatment Detection- and pain thresholds for mechanical (mNewton) stimuli on arm treated with lidocaine 45 minutes after drug application Detection- and pain thresholds for mechanical (mNewton) stimuli on arm treated with ethanol 45 minutes after drug application | 45 minutes |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |