Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients

NCT ID: NCT05857098

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-06-01

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.

Conditions

Cluster Headache; Trigeminal Autonomic Cephalgia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Local Field potential recording

Continuous recording of Local Field potentials in patients implanted with Deep brain stimulation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Anne BALOSSIER, MD

Role: CONTACT

anne.balossier@ap-hm.fr

0491384277 ext. +33

Emilie GARRIDO-PRADALIE

Role: CONTACT

Emilie.GARRIDO-PRADALIE@ap-hm.fr

0491382061 ext. +33

Facility Contacts

Anne BALOSSIER, MD

Role: primary

Other Identifiers

RCAPHM23_0056

Identifier Type: -

Identifier Source: org_study_id