Refractory EpilepsyNCT06524479
Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG
A study testing SEEG recordings and SPES in people with Refractory Epilepsy and Sleep, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Refractory Epilepsy, Sleep
- What is being tested?
- SEEG recordings and SPES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2024to 8 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Drug-resistant focal epilepsy
- Justified SEEG exploration in the context of presurgical assessment of epilepsy
- Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis
- Written non-opposition to study participation
Who cannot join
- Pregnant women (Contraindication to SEEG exploration)
- Subjects that experience surgical complications during the implant procedure will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, 100000
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
About this study
This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.
Read the detailed description
Sleep serves as a fundamental physiological state whose disruption has profound implications for neurological health. The daily alternation between sleep and wakefulness reflects an intrinsic circadian rhythm that orchestrates critical fluctuations in cortical excitability and functional connectivity throughout the brain. The cerebral cortex, comprising approximately 80% of total brain volume, forms the neural substrate for higher-order cognitive functions including sensory perception, executive control, and memory processes. Importantly, sleep acts as a global brain modulator that dynamically reorganizes patterns of neural communication across distributed cortical and subcortical networks.
Stereoelectroencephalography (SEEG) provides direct access to intracranial electrophysiological activity with exceptional spatiotemporal resolution. When combined with single-pulse electrical stimulation (SPES), this powerful methodology enables quantitative assessment of inter-regional connectivity through analysis of evoked potentials, allowing precise characterization of both connection strength and directionality. This integrated approach offers unique opportunities to examine how different vigilance states modulate cortical excitability and reorganize functional brain networks, particularly in clinical populations with neurological disorders. The ability to track state-dependent changes in network dynamics provides crucial insights into both normal brain function and pathological conditions.
- Conditions
- Refractory Epilepsy, Sleep
- Being tested
- SEEG recordings and SPES
- Keywords
- homeostatic sleep pressure, synaptic plasticity
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEG recordings and SPESProcedure or surgery
This study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics.
| Study group | Role | What they receive |
|---|---|---|
| SEEG recordings and SPES effects | Experimental | Single-pulse electrical stimulation (SPES) evokes transient neuronal responses that propagate through functional networks, providing a powerful tool to map brain connectivity. When delivered at low frequencies (0.05 Hz, every 20 s), SPES allows quantitative assessment of dynamic network interactions while avoiding long-term synaptic modifications. These stimulation-induced responses, recorded via stereoelectroencephalography (SEEG), reveal both local and distributed neural activity with millisecond precision. Receives: Procedure: SEEG recordings and SPES |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEEG recordings with SPES during daytime and sleeptime
Single-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.
Measured: 48 hours
Secondary outcomes (6)
Dynamic melatonin levels
Collection of melatonin during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement. Salivary melatonin was measured by radioimmunoassay.
Measured: 48 hours
Dynamic cortisone levels
Collection of salivary cortisone during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Measured: 48 hours
Dynamic 11-Deoxycortisol levels
Collection of salivary 11-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Measured: 48 hours
Dynamic 21-Deoxycortisol levels
Collection of salivary 21-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Measured: 48 hours
Dynamic 18-Hydroxycortisol levels
Collection of salivary 18-Hydroxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Measured: 48 hours
Dynamic 18-Oxocortisol levels
Collection of salivary 18-Oxocortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start8 Jul 2024
- Primary completion7 Jun 2026 (estimated)
- Study completion8 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524479
- Sponsor's protocol ID
- 2024-208-002
- Status last verified
- Jun 2025
- First submitted
- 23 Jul 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG
- ClinicalTrials.gov ID
- NCT06524479
- Acronym / sponsor ID
- 2024-208-002
- Conditions
- Refractory Epilepsy, Sleep
- Keywords
- homeostatic sleep pressure, synaptic plasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 8 Oct 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.
Detailed description
Sleep serves as a fundamental physiological state whose disruption has profound implications for neurological health. The daily alternation between sleep and wakefulness reflects an intrinsic circadian rhythm that orchestrates critical fluctuations in cortical excitability and functional connectivity throughout the brain. The cerebral cortex, comprising approximately 80% of total brain volume, forms the neural substrate for higher-order cognitive functions including sensory perception, executive control, and memory processes. Importantly, sleep acts as a global brain modulator that dynamically reorganizes patterns of neural communication across distributed cortical and subcortical networks.
Stereoelectroencephalography (SEEG) provides direct access to intracranial electrophysiological activity with exceptional spatiotemporal resolution. When combined with single-pulse electrical stimulation (SPES), this powerful methodology enables quantitative assessment of inter-regional connectivity through analysis of evoked potentials, allowing precise characterization of both connection strength and directionality. This integrated approach offers unique opportunities to examine how different vigilance states modulate cortical excitability and reorganize functional brain networks, particularly in clinical populations with neurological disorders. The ability to track state-dependent changes in network dynamics provides crucial insights into both normal brain function and pathological conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEEG recordings and SPES effects | Experimental | Procedure: SEEG recordings and SPESSingle-pulse electrical stimulation (SPES) evokes transient neuronal responses that propagate through functional networks, providing a powerful tool to map brain connectivity. When delivered at low frequencies (0.05 Hz, every 20 s), SPES allows quantitative assessment of dynamic network interactions while avoiding long-term synaptic modifications. These stimulation-induced responses, recorded via stereoelectroencephalography (SEEG), reveal both local and distributed neural activity with millisecond precision. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Drug-resistant focal epilepsy
- Justified SEEG exploration in the context of presurgical assessment of epilepsy
- Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis
- Written non-opposition to study participation
Key exclusion criteria (2 listed)
- Pregnant women (Contraindication to SEEG exploration)
- Subjects that experience surgical complications during the implant procedure will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEEG recordings and SPESThis study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics. | Procedure or surgery | SEEG recordings and SPES effects |
Primary outcome
SEEG recordings with SPES during daytime and sleeptime
Time frame: 48 hours
Single-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.
6 secondary outcomes
Dynamic melatonin levels
Time frame: 48 hours
Dynamic cortisone levels
Time frame: 48 hours
Dynamic 11-Deoxycortisol levels
Time frame: 48 hours
Dynamic 21-Deoxycortisol levels
Time frame: 48 hours
Dynamic 18-Hydroxycortisol levels
Time frame: 48 hours
Dynamic 18-Oxocortisol levels
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEG recordings and SPES in people with Refractory Epilepsy and Sleep, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liankun Ren, MD (13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEEG recordings with SPES during daytime and sleeptime (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.