QST, Blink Reflex and Nociceptive Flexion Reflex in Headache

Head Pain Clinical Trial

Official title:

Quantitative Sensory Testing, Blink Reflex and Nociceptive Flexion Reflex in the Pathophysiology of Headache

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04585698
• Other study ID #: ULiege_CHEPS_AM_MM_JS
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: October 2021

Study information

• Verified date: September 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: patients with headache which are about to receive a treatment with fremanezumab

Exclusion Criteria:

• medication changes 1 month prior to the test

• neuropathy

• acute or chronic pain

• medications having effects on the central nervous system

• other disease

Related Conditions & MeSH terms

• Head Pain
• Headache

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modulation of pain threshold by fremanezumab	quantitative analysis of pain-related reflexes with QST (quantitative sensory testing) using Medoc Pathway	one year
Primary	modulation of pain threshold by fremanezumab	Blink reflex and nociceptive flexion reflex usig EMG Viking Viasys.	one year