Durham, NCNCT07605858Now EnrollingIRB Ready

Patients With Drug-resistant Focal Epilepsy Clinical Trial in Durham, NC

Access cutting-edge patients with drug-resistant focal epilepsy treatment through this clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Hospices Civils de Lyon

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Access patients with drug-resistant focal epilepsy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related patients with drug-resistant focal epilepsy treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Patients With Drug-resistant Focal Epilepsy Study in Durham

Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure susceptibility. Conversely, sleep disturbances are highly prevalent in patients with epilepsy (PWE). Using simultaneous stereoelectroencephalography (SEEG)-polysomnography, the investigators previously showed that sleep fragmentation in focal drug-resistant epilepsy is associated with both ictal and interictal epileptic activity, with increased interictal epileptiform discharges (IED) immediately before and during arousals. However, causality remains unclear, as sleep instability itself may promote epileptic discharges. Determining whether nocturnal seizures and IED directly induce awakenings is clinically important. Nocturnal epileptic activity is often considered less disabling than daytime seizures and rarely guides treatment decisions, yet demonstrating a direct impact on sleep continuity could support therapeutic strategies specifically targeting nocturnal epileptic activity to improve sleep quality. Beyond sleep continuity, epilepsy may also influence cognitive processes during sleep, including subjective sleep depth and dreaming. While the cognitive consequences of epilepsy during wakefulness are well established, relationships between epileptic activity, sleep architecture and subjective sleep experiences remain poorly understood. In a survey of 300 PWE, the investigators observed altered dream recall frequency and dream content, with seizure-related dreams associated with nocturnal seizures. However, retrospective morning reports cannot establish temporal relationships between epileptic discharges and dream phenomena, nor determine the influence of discharge localization or sleep stage. SEEG combined with direct electrical stimulation (DES) provides a unique framework to address these questions. DES is routinely used during presurgical evaluation to identify epileptogenic and eloquent cortex, but is mainly performed during wakefulness. Yet sleep modifies functional connectivity and facilitates epileptic activity, suggesting that DES during sleep may increase the sensitivity of stimulation-based localization of the seizure-onset zone. The EPIDREAM 3 study will investigate whether DES-induced epileptic activity during sleep provokes arousals, alters dream recall or content, and modifies perceived sleep depth. It will also assess whether sleep-related DES improves delineation of epileptogenic networks, particularly in sleep-related epilepsies. Detailed description: Patients with frontal or temporal drug-resistant focal epilepsy investigated with SEEG as part of presurgical evaluation will be included in the Department of Functional Neurology and Epileptology of the HCL, Lyon. The investigators will use intra-cranial DES performed during the SEEG investigation to explore the impact of focal induced epileptic activity on arousal and dreams. 1. DES will be first performed during wake as part of routine SEEG evaluation with the double purpose of localizing the seizure onset zone and providing a functional mapping. This step identifies channels: (i) in the assumed SOZ, where DES induces after-discharges with/without seizure symptoms; (ii) in the assumed SOZ, where DES induces no after-discharge/seizure but may induce clinical symptoms; (iii) in non-epileptic areas, where stimulation induces neither. For temporal lobe epilepsy, control channels will be selected in the frontal lobe; for frontal lobe epilepsy, in the temporal lobe 2. Stimulations will be repeated in REM and NREM sleep (N2/N3) during the first two sleep cycles of a single night with simultaneous PSG. The investigators will assess for each stimulation: (1) the precise location of the channel (2) the presence and characteristics of an induced after-discharge or seizure (3) presence of a spontaneous arousal (3-15 sec) or awakening (\> 15 sec) (4) presence of objective symptoms (5) in case of awakening: presence of subjective reported symptoms, sleep depth and mind content

Sponsor: Hospices Civils de Lyon

Who Can Participate

Inclusion Criteria

Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
Aged 18 to 55 years old
Diagnosis of focal temporal or frontal lobe epilepsy based on non-invasive work-up
Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy 31
Patients undergoing SEEG investigation
At least 1 frontal and 1 temporal electrode in the SEEG procedure
Patient affiliated to the French health care system

Exclusion Criteria

Multifocal epilepsy
Untreated severe obstructive sleep-apnea syndrome
Too abnormal SEEG recording interfering with sleep stage identification during the DES procedure
Severe cognitive impairment preventing full understanding and completion of the protocol
Unstable psychiatric condition
Subject participating in other interventional research with an exclusion period still in progress at pre-inclusion
Persons deprived of their liberty by a judicial or administrative decision
Adults subject to a legal protection measure (guardianship, curatorship
Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT07605858) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Patients With Drug-resistant Focal Epilepsy Treatment Options in Durham, NC

If you're searching for patients with drug-resistant focal epilepsy treatment options in Durham, NC, this clinical trial (NCT07605858) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced patients with drug-resistant focal epilepsy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all patients with drug-resistant focal epilepsy clinical trials near you to find additional studies recruiting in your area.

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