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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cluster Headache; Trigeminal Autonomic Cephalgia
• Intervention / Treatment: Other: Local Field potential recording

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

• Study Contact: Name: Anne BALOSSIER, MD; Phone Number: +33 0491384277; Email: anne.balossier@ap-hm.fr
• Study Contact Backup: Name: Emilie GARRIDO-PRADALIE; Phone Number: +33 0491382061; Email: Emilie.GARRIDO-PRADALIE@ap-hm.fr

Study Locations

• France
  • Marseille, France
    • Assistance Publique Hopitaux de Marseille
    • Contact: Anne BALOSSIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from refractry chronic cluster headache

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Local field potentials	Local field potentials amplitudes registered by the patient during a cluster attack	Between 0 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Efficacy of deep brain stimulation on attacks frequency	Frequency of cluster attacks	Between 0 to 12 months
Change in Efficacy of deep brain stimulation on pain intensity	Pain intensity of cluster attacks	Between 0 to 12 months
Change Efficacy of deep brain stimulation in attacks duration	Duration of cluster attacks	Between 0 to 12 months
Change in Efficacy of deep brain stimulation on treatment	Medical treatments for cluster headache	Between 0 to 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypothalamus; Local Fields Potentials
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Cluster Headache; Trigeminal Autonomic Cephalalgias
• Other Study ID Numbers: RCAPHM23_0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No