An observational study in Cluster Headache and Trigeminal Autonomic Cephalgia, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Assistance Publique Hopitaux De Marseille · Observational
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.
Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor...) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity...). As it is a feasibility study, only 5 patients will be included.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 5 is below the median of 68 across 32 observational studies indexed under Cluster Headache.
Browse Cluster Headache studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from refractry chronic cluster headache
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous recording of Local Field potentials in patients implanted with Deep brain stimulation
Change in Local field potentials
Local field potentials amplitudes registered by the patient during a cluster attack
Time frame: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on attacks frequency
Frequency of cluster attacks
Time frame: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on pain intensity
Pain intensity of cluster attacks
Time frame: Between 0 to 12 months
Change Efficacy of deep brain stimulation in attacks duration
Duration of cluster attacks
Time frame: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on treatment
Medical treatments for cluster headache
Time frame: Between 0 to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Jun 2025, 24 months later.
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This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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