Impact of the brain’s adenosine pathway on epilepsy and arousal in adults
Official title: Impact of Epilepsy on the Brainstem Adenosine Pathway and Its Relation With Arousal and Respiratory Reactivity
Run by Hospices Civils de Lyon · NCT07249034 · Data updated 2026-11-12
This study tests how the brain’s adenosine system affects arousal and breathing in adults with drug-resistant focal epilepsy compared with healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | October 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07249034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–55 with drug-resistant focal epilepsy or idiopathic generalized epilepsy, meeting defined seizure and treatment criteria, and healthy volunteers for comparison.
✕Probably not a fit
Participants with conditions or circumstances that affect respiratory control or those unable to tolerate imaging procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use a hypercapnic challenge during PET/MRI to explore how adenosine signaling in the brainstem relates to seizure-related respiratory control. Participants include adults with focal or generalized epilepsy and healthy controls, to compare brain activity and adenosine pathway engagement. The study uses [18F]CPFPX PET imaging alongside MRI to map brain regions involved in arousal and breathing during wakefulness. Outcomes may help explain mechanisms behind postictal respiratory dysfunction and SUDEP risk. The trial is conducted at Hospices Civils de Lyon with a single intervention session.
Why it matters
Potential benefit: If successful, the findings could inform new approaches to reduce postictal respiratory impairment and SUDEP risk in people with epilepsy.
How similar studies have gone: Previous research has explored adenosine pathways in epilepsy, but this specific brainstem-respiration-focused PET/MRI approach is exploratory and novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * For patients 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old 3. Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy 4. Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy as failure of adequate trials of two tolerated, appropriately chosen and used antiseizure drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom 5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months 6. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2) * For healthy volunteers 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old 3. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2) Exclusion Criteria: * For patients 1. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency 2. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure 3. Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist. 4. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not 5. Ongoing treatment with selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitors): Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors): Duloxetine, Milnacipran, Venlafaxine 6. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan) 7. MRI contra-indication (presence of metallic elements, claustrophobia) 8. Patient treated with vagal nerve stimulation or deep brain stimulation 9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0 10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures 11. Persons deprived of their liberty by a judicial or administrative decision 12. Adults subject to a legal protection measure (guardianship, curatorship) 13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 14. Positive urine pregnancy test at V2, if applicable 15. Hypersensitivity to \[18F\]-CPFPX * For healthy volunteers 1. History of epilepsy 2. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency 3. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure 4. Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist. 5. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not 6. Ongoing treatment with selective serotonin reuptake inhibitor : SSRIs (Selective Serotonin Reuptake Inhibitors) : Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) : Duloxetine, Milnacipran, Venlafaxine 7. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan) 8. MRI contra-indication (presence of metallic elements, claustrophobia) 9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0 10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures 11. Persons deprived of their liberty by a judicial or administrative decision 12. Adults subject to a legal protection measure (guardianship, curatorship) 13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 14. Positive urine pregnancy test at V2, if applicable 15. Hypersensitivity to \[18F\]-CPFPX
Where it's running
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Hospices Civils de Lyon
Bron, France Recruiting
Study contacts
- Principal investigator: Sylvain RHEIMS, PUPH — Hospices Civils de Lyon
- Study coordinator: Sylvain RHEIMS, PUPH
- Email: sylvain.rheims@chu-lyon.fr
- Phone: +33472357106
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.