Head PainNCT04585698
QST, Blink Reflex and Nociceptive Flexion Reflex in Headache
An observational study of Head Pain, run by University of Liege.
Trial summary
The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Pain
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Oct 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with headache before and 1 month after receiving fremanezumab Age: 18-65 years Sex: 2/3 female, 1/3 male
Who may be able to join
None listed.
Who cannot join
- medication changes 1 month prior to the test
- neuropathy
- acute or chronic pain
- medications having effects on the central nervous system
- other disease
About this study
Official title: Quantitative Sensory Testing, Blink Reflex and Nociceptive Flexion Reflex in the Pathophysiology of Headache
The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).
Read the detailed description
20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.
- Conditions
- Head Pain
- Keywords
- headache, fremanezumab, blink reflex, nociceptive flexion reflex, quantitative sensory testing
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| headache patients | Not described | |
| healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
modulation of pain threshold by fremanezumab
quantitative analysis of pain-related reflexes with QST (quantitative sensory testing) using Medoc Pathway
Measured: one year
modulation of pain threshold by fremanezumab
Blink reflex and nociceptive flexion reflex usig EMG Viking Viasys.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manise Maite, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585698
- Sponsor's protocol ID
- ULiege_CHEPS_AM_MM_JS
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing, Blink Reflex and Nociceptive Flexion Reflex in the Pathophysiology of Headache
- ClinicalTrials.gov ID
- NCT04585698
- Acronym / sponsor ID
- ULiege_CHEPS_AM_MM_JS
- Conditions
- Head Pain
- Keywords
- headache, fremanezumab, blink reflex, nociceptive flexion reflex, quantitative sensory testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).
Detailed description
20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| headache patients | – | – |
| healthy subjects | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with headache before and 1 month after receiving fremanezumab Age: 18-65 years Sex: 2/3 female, 1/3 male
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- medication changes 1 month prior to the test
- neuropathy
- acute or chronic pain
- medications having effects on the central nervous system
- other disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modulation of pain threshold by fremanezumab
Time frame: one year
quantitative analysis of pain-related reflexes with QST (quantitative sensory testing) using Medoc Pathway
modulation of pain threshold by fremanezumab
Time frame: one year
Blink reflex and nociceptive flexion reflex usig EMG Viking Viasys.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Pain, run by University of Liege.
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 0 inclusion and 5 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modulation of pain threshold by fremanezumab (time frame: one year). The study lists 2 primary outcomes in all. 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 14 Oct 2020.