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

NCT ID: NCT05699317

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Thermal stimuli

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers between 26 and 75 years old having a normal baseline testing.

Exclusion Criteria

• Age<26 and >75 years old
• Known neurological condition.
• Acute or chronic pain condition.
• Currently taking drugs that may influence the recording of evoked potentials (analgesics, psychotropic substances, antiepileptics…).
• History of neurological, or metabolic disorder.
• Inability to complete study task.
• History of chemotherapy.
• Habitual substance abuse(alcoholic beverages intake >21 units/week for males, >14 units/week for females.)
• Being a volley ball player (due to risk of modified sensibility of the volar forearm skin)
• Abnormal baseline neurological, SNC or QST testing

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

André Mouraux, Prof

Role: PRINCIPAL_INVESTIGATOR

UCLouvain, IONS

Locations

Institute of Neuroscience

Brussels, Woluwe Saint Lambert, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Yoshnee Foolchand, MD

Role: CONTACT

yoshnee.foolchand@student.uclouvain.be

+32483438840

André Mouraux, Pr

Role: CONTACT

andre.mouraux@uclouvain.be

+32 2 764 73 86

Facility Contacts

André MOURAUX, Pr

Role: primary

andre.mouraux@uclouvain.be

+32 2 764 73 86

Yoshnee FOOLCHAND, Dr

Role: backup

yoshnee.foolchand@student.uclouvain.be

+32483438840

Other Identifiers

PET ET PSYCHOMOT

Identifier Type: -

Identifier Source: org_study_id