Clinical trial NCT05857098: Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients
Official title: Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients Treated by Deep Brain Stimulation : a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cluster Headache
Trigeminal Autonomic Cephalgia
Keywords: Hypothalamus
Local Fields Potentials
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from refractry chronic cluster headache

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache
* Patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon
* Patients implanted with a deep brain stimulation system PerceptTM Medtronic®

Exclusion Criteria:

* Secondary cluster headache
* Patients implanted with another device of deep brain stimulation

Primary outcomes:
measure: Change in Local field potentials
timeFrame: Between 0 to 12 months
Secondary outcomes:
measure: Change in Efficacy of deep brain stimulation on attacks frequency
timeFrame: Between 0 to 12 months
measure: Change in Efficacy of deep brain stimulation on pain intensity
timeFrame: Between 0 to 12 months
measure: Change Efficacy of deep brain stimulation in attacks duration
timeFrame: Between 0 to 12 months
measure: Change in Efficacy of deep brain stimulation on treatment
timeFrame: Between 0 to 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References: