Establishing Normative Values of Cold and Contact Heat-evoked PotentialsNCT05699317
Clinical Use of Cold and Contact Heat-evoked Potentials: Normative Values
A study testing Thermal stimuli in people with Establishing Normative Values of Cold and Contact Heat-evoked Potentials, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Establishing Normative Values of Cold and Contact Heat-evoked Potentials
- What is being tested?
- Thermal stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between 26 and 75 years old having a normal baseline testing.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Institute of Neuroscience
Brussels, Woluwe Saint Lambert, 1200
André MOURAUX, Pr, +32 2 764 73 86, andre.mouraux@uclouvain.be
Yoshnee FOOLCHAND, Dr, +32483438840, yoshnee.foolchand@student.uclouvain.be
About this study
Official title: 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.
Read the 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.
- Being tested
- Thermal stimuli
- Keywords
- Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stimuliOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Thermal stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Establishing Normative Values of Cold and Contact Heat-evoked PotentialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Mouraux, Prof, Principal investigator, UCLouvain, IONS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699317
- Sponsor's protocol ID
- PET ET PSYCHOMOT
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Normative Values for the Clinical Use of Cold and Contact Heat-evoked Potentials
- ClinicalTrials.gov ID
- NCT05699317
- Acronym / sponsor ID
- PET ET PSYCHOMOT
- Keywords
- Healthy participants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Thermal stimuli |
Who may qualify
- Ages
- 26 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers between 26 and 75 years old having a normal baseline testing.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal stimuliThermal 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. | Other | Intervention |
Primary outcome
Evoked potentials variables
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Mouraux, Prof principal investigator
UCLouvain, IONS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal stimuli in people with Establishing Normative Values of Cold and Contact Heat-evoked Potentials, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshnee Foolchand, MD (+32483438840, yoshnee.foolchand@student.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked potentials variables (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.