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

Sponsor

Université Catholique de Louvain (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699317

Collaborator

(none)

Enrollment

Arm

8.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Establishing Normative Values for the Clinical Use of Cold and Contact Heat-evoked Potentials	Other: Thermal stimuli	N/A

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:

brief neurological examination
sensory nerve conduction study-related
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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evoked potentials variables [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

26 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Université Catholique de Louvain

Investigators

Principal Investigator: André Mouraux, Prof, UCLouvain, IONS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT05699317

Other Study ID Numbers:

PET ET PSYCHOMOT

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 26, 2023