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Not yet recruitingNCT05857098DETECTUpdated May 12, 2023

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

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

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
5
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cluster Headache
  • Trigeminal Autonomic Cephalgia

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Keywords

  • Hypothalamus
  • Local Fields Potentials
03

In context

Cluster Headache

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Adult patients (age : 18-70 years-old) suffering from 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

Exclusion Criteria:

  • Secondary cluster headache
  • Patients implanted with another device of deep brain stimulation
Terms in these criteria, in plain language(1)

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 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.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
5 participants (estimated)
Patient registry
No

Interventions

  • OtherLocal Field potential recording

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

06

What researchers measure

Primary outcomes

  1. Change in Local field potentials

    Local field potentials amplitudes registered by the patient during a cluster attack

    Time frame: Between 0 to 12 months

Secondary outcomes

  1. Change in Efficacy of deep brain stimulation on attacks frequency

    Frequency of cluster attacks

    Time frame: Between 0 to 12 months

  2. Change in Efficacy of deep brain stimulation on pain intensity

    Pain intensity of cluster attacks

    Time frame: Between 0 to 12 months

  3. Change Efficacy of deep brain stimulation in attacks duration

    Duration of cluster attacks

    Time frame: Between 0 to 12 months

  4. Change in Efficacy of deep brain stimulation on treatment

    Medical treatments for cluster headache

    Time frame: Between 0 to 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2023; primary completion for Jun 2025, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2023
First posted
May 12, 2023
StartEst.
May 31, 2023
Primary completionEst.
Jun 1, 2025
CompletionEst.
Jun 1, 2025
Last update
May 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05857098
Responsible party
Sponsor
First posted
May 12, 2023
Start date
May 31, 2023 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
May 12, 2023

Study contacts

Anne BALOSSIER, MD
Contact
anne.balossier@ap-hm.fr
0491384277 ext. +33
Emilie GARRIDO-PRADALIE
Contact
Emilie.GARRIDO-PRADALIE@ap-hm.fr
0491382061 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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