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

Cluster Headache Clinical Trial

— DETECT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05857098
• Other study ID #: RCAPHM23_0056
• Status: Not yet recruiting
• Start date: May 31, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Anne BALOSSIER, MD
• Phone: 0491384277
• Email: anne.balossier[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Trigeminal Autonomic Cephalgia

Intervention

Other:
• Local Field potential recording
Continuous recording of Local Field potentials in patients implanted with Deep brain stimulation

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Local field potentials	Local field potentials amplitudes registered by the patient during a cluster attack	Between 0 to 12 months
Secondary	Change in Efficacy of deep brain stimulation on attacks frequency	Frequency of cluster attacks	Between 0 to 12 months
Secondary	Change in Efficacy of deep brain stimulation on pain intensity	Pain intensity of cluster attacks	Between 0 to 12 months
Secondary	Change Efficacy of deep brain stimulation in attacks duration	Duration of cluster attacks	Between 0 to 12 months
Secondary	Change in Efficacy of deep brain stimulation on treatment	Medical treatments for cluster headache	Between 0 to 12 months