NCT07791004|Not Yet Recruiting
Loading search results
Sponsor study identifier
observational
60
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Persistent non-dental orofacial pain is common yet poorly characterised, and its pathophysiology remains largely unknown. Two clinically similar entities are distinguished: post-traumatic trigeminal neuropathic pain (PTNP), in which peripheral nerve damage is demonstrable, and persistent idiopathic facial pain (PIFP), in which peripheral findings are typically absent - pointing to an altered central processing of trigeminal nociceptive input. This monocentric study characterises the peripheral and central mechanisms of PIFP by comparing PIFP patients with age- and sex-matched healthy controls using a combination of non-invasive peripheral and central approaches. The study comprises two work packages. The peripheral work package uses quantitative sensory testing (standardised DFNS protocol) to test the hypothesis that PIFP patients retain an intact peripheral nervous system. The central work package uses functional MRI with standardised trigemino-nociceptive stimulation to characterise brainstem network dynamics, testing the hypothesis that PIFP patients exhibit a central trigeminal processing disturbance at the brainstem level. In PIFP patients, the functional MRI is repeated before and after a local-anaesthetic nerve block in the pain area, additionally distinguishing patients whose pain is completely abolished by the block from those with persistent pain despite it. The overarching aim is to characterise the pathophysiological basis of PIFP and thereby advance the mechanistic understanding of persistent orofacial pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2026
Actual (reported)August 27, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Difference in brain functional neuroimaging response to standardized trigemino-nociceptive stimulation between PIFP patients HC
BOLD signal change (contrast estimates, arbitrary units) during standardized trigemino-nociceptive stimulation versus baseline, compared between PIFP patients and HC in a priori defined regions of interest and at whole-brain level.
Baseline (MRI session before local anesthesia)
Difference in brain activation before versus after the local-anesthetic nerve block, and between complete responders and non-responders
BOLD signal change (contrast estimates, arbitrary units) during standardized trigemino-nociceptive stimulation, compared within participants before versus after the local-anesthetic nerve block, and between participants whose pain is completely abolished by the block and those with persistent pain despite the block
Pre-block MRI at baseline and post-block MRI, both on the same day 1
Comparison of deep phenotyping and quantitative sensory testing (QST) parameters between the study cohorts (PIFP versus HC).
Baseline (single assessment before local anesthesia)
Patients with persistent idiopathic facial pain
Patients with PIFP will be recruited from the headache/facial pain outpatient clinic of the University Medical Center Hamburg-Eppendorf
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Ziegeler C, Schulte LH, May A. Altered trigeminal pain processing on brainstem level in persistent idiopathic facial pain. Pain. 2021 May 1;162(5):1374-1378. doi: 10.1097/j.pain.0000000000002126.
Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.
Arne May, MD, PhD
Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf
First Submitted
August 18, 2026
First Posted
August 27, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2029
Contact the study team to confirm eligibility.
May A, Ciancia V, Basedau H. Visualizing nociplastic pain: functional hyperexcitability in neuropathic and idiopathic facial pain syndromes. J Headache Pain. 2025 Oct 13;26(1):211. doi: 10.1186/s10194-025-02133-w.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
Individual participant data (IPD) will not be shared with other researchers. Data are collected and analyzed in pseudonymized form, and results will be reported and published only in aggregated, anonymized form that does not permit identification of individual participants. The pseudonymization key is held exclusively by the study leadership and is deleted as soon as the research purpose allows. Consistent with the informed consent obtained from participants and the approved data protection concept, no de-identified individual-level datasets will be made available externally.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: