NCT05699317

Clinical Use of Cold and Contact Heat-evoked Potentials: Normative Values

Establishing Normative Values for the Clinical Use of Cold and Contact Heat-evoked Potentials

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 26 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This prospective interventional study aims at recording contact heat evoked potentials (CHEPs) and cold evoked potentials (CEPs) in a healthy population sample in an aim to derive normative values which could be used to evaluate evoked potentials (EPs) of patients.

Detailed description

Population sample of 80 healthy volunteers between 26 and 75 years old will be recruited and will be categorized into 5 age subgroups (26-35, 36-45, 46-55, 56-65, 66-75 years old). Upon arrival, participants will be reminded of the aims and of the content of the experiment. After informed consent (recorded in writing), healthy subjects will be screened with a baseline examination: 1. brief neurological examination 2. sensory nerve conduction study-related 3. quantitative sensory testing If the baseline examination screening is considered normal, CEPs and CHEPs will be performed. To avoid bias, the side and order of the tests will be randomized. All thermal stimuli for CEPs and CHEPs will be delivered delivered using a contact thermal stimulator (TCS model II.1, QST.Lab, Strasbourg, France). Only stimuli that are safe and acceptable for the subject will be used in the study, and all experimental procedures can be interrupted at any time by the participant, with no detrimental effect.

Conditions

• Establishing Normative Values of Cold and Contact Heat-evoked Potentials

Interventions

Type	Name	Description
OTHER	Thermal stimuli	Thermal stimuli will be delivered delivered using a contact thermal stimulator (TCS model II.1, QST.Lab, Strasbourg, France). Target temperatures will be set to reach 10°C (CEP) and 60°C (CHEP) at a rate of 300°C/s. Stimulus duration will be set 200 ms. The stimulator will be manually held against the skin by the experimenter and slightly displaced within the first 10 cm of the distal extremity of the volar forearm being investigated, marked on the skin of the participant, after each stimulus. A total of 30 stimuli per temperature and testing site will be applied.

Timeline

• Start date: 2023-01-20
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-01-26
• Last updated: 2023-03-13

Locations

1 site across 1 country: Belgium