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

NCT05699317 | Unknown

• 1 other identifier: PET ET PSYCHOMOT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Establishing Normative Values of Cold and Contact Heat-evoked Potentials

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Other: Thermal stimuli

Interventions

Thermal stimuli 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.

Intervention

Eligibility Criteria

• Age: 26 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Institute of Neuroscience

Brussels, Woluwe Saint Lambert, 1200, Belgium

RECRUITING

Study Officials

• André Mouraux, Prof

  UCLouvain, IONS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshnee Foolchand, MD

CONTACT

+32483438840; yoshnee.foolchand@student.uclouvain.be

André Mouraux, Pr

CONTACT

+32 2 764 73 86; andre.mouraux@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 20, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)