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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04865185
Other study ID # TLH21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date February 28, 2022

Study information

Verified date March 2021
Source University of Aarhus
Contact Ellen L Schaldemose, MD
Phone +45 93501942
Email ells@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy subjects - Age between 18 and 40 years - Participant is able and willing to give informed consent. Exclusion Criteria: - Unable to understand and speak Danish - Non-cooperative - Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation - Pain medication within the last week - Medication within the last week that can affect assessment - Psychiatric or neurological disease and diseases that may affect the assessment - Sensory disturbances - History or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases) - Pregnancy or lactation - Jetlag or sleep deprivation - Alcohol or drug abuse - Consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours - Any abnormality of the skin or of vascular origin at application site - History of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Xylocaine spray 100mg/ml
Topical application
Ethanol
Topical application

Locations

Country Name City State
Denmark Danish Pain Research Center, Aarhus University, Aarhus University Hospital Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Primary 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
Secondary 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
Secondary Quality of the Thermal Grill (TG) 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Paradoxical heat sensation (PHS) Number of PHS responders at baseline without any treatment, 30 minutes before drug application 30 minutes before drug application
Secondary Thermal Grill (TG) Number of TG responders at baseline without any treatment 20 minutes before drug application 20 minutes before drug application
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