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

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.

Study Overview

• Status: Recruiting
• Conditions: Establishing Normative Values of Cold and Contact Heat-evoked Potentials
• Intervention / Treatment: Other: Thermal stimuli

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoshnee Foolchand, MD; Phone Number: +32483438840; Email: yoshnee.foolchand@student.uclouvain.be
• Study Contact Backup: Name: André MOURAUX, Pr; Phone Number: +32 2 764 73 86; Email: andre.mouraux@uclouvain.be

Study Locations

• Belgium
  • Woluwe Saint Lambert
    • Brussels, Woluwe Saint Lambert, Belgium, 1200
      • Recruiting
      • Institute of Neuroscience
      • Contact: André MOURAUX, Pr; Phone Number: +32 2 764 73 86; Email: andre.mouraux@uclouvain.be
      • Contact: Yoshnee FOOLCHAND, Dr; Phone Number: +32483438840; Email: yoshnee.foolchand@student.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evoked potentials variables	Three peaks will be identified in the individual average waveforms of the ERPs elicited by noxious heat and innocuous cold stimulation: a negative-positive complex maximal at the scalp vertex (N2-P2) and an earlier negative wave maximal over the hemisphere contralateral to the stimulated forearm (N1). Latencies and amplitude of the N2 and P2 peaks will be identified at the vertex electrode (Cz) referenced to the mastoids (M1M2). The latency and amplitude of the earlier N1 will be identified at the temporal electrode contralateral to the stimulated arm (Tc) referenced to the frontal midline electrode (Fz). Descriptive statistics will be computed for the evoked potentials variables: N1, N2, P2 latencies as well as N1, N2P2 amplitudes, according to gender, height and age category	6 months

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: André Mouraux, Prof, UCLouvain, IONS

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Healthy participants
• Other Study ID Numbers: PET ET PSYCHOMOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No