EpilepsyNCT06667232
Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG
A study testing Single-pulse stimulation, Paired-pulse stimulation and Stepwise frequency stimulation in people with Epilepsy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The study aims to evaluate modulation effects of burst stimulation patterns via SEEG. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Single-pulse stimulation, Paired-pulse stimulation and Stepwise frequency stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2025to 1 Dec 2026
- 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)
- Psychiatric disorders
- History of psychotic disorders
- History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
- 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,Capital Medical University
Beijing, Beijing Municipality, 100053
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
Liankun Ren, MD
About this study
The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.
Read the detailed description
Our research group plans to conduct a study on patients with drug-resistant epilepsy who have SEEG electrodes implanted. The study will evaluate and compare the modulation effect of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation via direct electrical stimulation using SEEG. The goal is to explore the focal and network modulation effect of distinct stimulation paradigms during the resting state and post-seizure state.
- Conditions
- Epilepsy
- Being tested
- Single-pulse stimulation, Paired-pulse stimulation, Stepwise frequency stimulation, Burst stimulation
- Keywords
- burst stimulation patterns, epilepsy, SEEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-pulse stimulationOther
Investigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials
Paired-pulse stimulationOther
The repetitive delivery of pairs of stimulation pulses is DES patten with a 5-50 ms interval between each pulse, constitutes repetitive paired-pulse stimulation.
Stepwise frequency stimulationOther
Stepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern.
Burst stimulationOther
Burst stimulation pattern consisting of short bursts delivered once a second and an intraburst frequency of 50 Hz, 100 Hz, 150 Hz, 175 Hz and 200 Hz
| Study group | Role | What they receive |
|---|---|---|
| Single-pulse stimulation | Experimental | Single pulse electrical stimulation (SPES) is an investigational direct electrical stimulation (DES) pattern. Direct cortical stimulation applied at a frequency of ∼1Hz can probe cortico-cortical connections by averaging electrocorticogram time-lock to the stimuli. Receives: Other: Single-pulse stimulation |
| Paired-pulse stimulation | Experimental | Paired-pulse stimulation paradigm associates a conditioning and a test stimulation to induce intracortical inhibition or facilitation by modifying the response amplitude. Receives: Other: Paired-pulse stimulation |
| Stepwise frequency stimulation | Experimental | Stepwise frequency stimulation is a DES protocol that incrementally increases the stimulation frequency, starting from a lower to higher. Receives: Other: Stepwise frequency stimulation |
| Burst stimulation | Experimental | Burst stimulation is a DES patterned repetitive stimulation method; it represents a "more precise" and "smarter" electrical stimulation paradigm. Within a group, high-frequency pulses are emitted, and between groups, low-frequency pulses are delivered. This pattern of pulse delivery more closely mimics the physiological activity of neurons within the brain. Receives: Other: Burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation Factor
Investigators calculate normalized the Modulation Factors of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation patterns using (stimulation-pre-stimulation)/(stimulation + pre-stimulation)
Measured: During the trial(up to 3 hours for each subject)
EEG power in spectral frequency bands
Using SEEG-implanted electrodes, the investigators applied electrical stimulation single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods.
EEG Frequency Bands delta (1-4 Hz) theta (5-8 Hz) alpha (9-12 Hz) beta (13-30 Hz) low gamma (31-70 Hz) high gamma (71-150 Hz)
Measured: During the trial(up to 3 hours for each subject)
Phase Locking Value
To estimate functional connectivity through the oscillatory synchrony of two brain regions, phase locking value (PLV) provides a measure of inter-regional synchrony based on phase difference between the paired signals.
Measured: During the trial(up to 3 hours for each subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start18 Jan 2025
- Primary completion25 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- NCT06667232
- Sponsor's protocol ID
- 2024-173-002
- Status last verified
- Jan 2025
- First submitted
- 27 Oct 2024
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG
- ClinicalTrials.gov ID
- NCT06667232
- Acronym / sponsor ID
- 2024-173-002
- Conditions
- Epilepsy
- Keywords
- burst stimulation patterns, epilepsy, SEEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Oct 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.
The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.
Detailed description
Our research group plans to conduct a study on patients with drug-resistant epilepsy who have SEEG electrodes implanted. The study will evaluate and compare the modulation effect of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation via direct electrical stimulation using SEEG. The goal is to explore the focal and network modulation effect of distinct stimulation paradigms during the resting state and post-seizure state.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-pulse stimulation | Experimental | Other: Single-pulse stimulationSingle pulse electrical stimulation (SPES) is an investigational direct electrical stimulation (DES) pattern. Direct cortical stimulation applied at a frequency of ∼1Hz can probe cortico-cortical connections by averaging electrocorticogram time-lock to the stimuli. |
| Paired-pulse stimulation | Experimental | Other: Paired-pulse stimulationPaired-pulse stimulation paradigm associates a conditioning and a test stimulation to induce intracortical inhibition or facilitation by modifying the response amplitude. |
| Stepwise frequency stimulation | Experimental | Other: Stepwise frequency stimulationStepwise frequency stimulation is a DES protocol that incrementally increases the stimulation frequency, starting from a lower to higher. |
| Burst stimulation | Experimental | Other: Burst stimulationBurst stimulation is a DES patterned repetitive stimulation method; it represents a "more precise" and "smarter" electrical stimulation paradigm. Within a group, high-frequency pulses are emitted, and between groups, low-frequency pulses are delivered. This pattern of pulse delivery more closely mimics the physiological activity of neurons within the brain. |
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 (5 listed)
- Pregnant women (Contraindication to SEEG exploration)
- Psychiatric disorders
- History of psychotic disorders
- History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
- 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 |
|---|---|---|
| Single-pulse stimulationInvestigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials | Other | Single-pulse stimulation |
| Paired-pulse stimulationThe repetitive delivery of pairs of stimulation pulses is DES patten with a 5-50 ms interval between each pulse, constitutes repetitive paired-pulse stimulation. | Other | Paired-pulse stimulation |
| Stepwise frequency stimulationStepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern. | Other | Stepwise frequency stimulation |
| Burst stimulationBurst stimulation pattern consisting of short bursts delivered once a second and an intraburst frequency of 50 Hz, 100 Hz, 150 Hz, 175 Hz and 200 Hz | Other | Burst stimulation |
Primary outcome
Modulation Factor
Time frame: During the trial(up to 3 hours for each subject)
Investigators calculate normalized the Modulation Factors of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation patterns using (stimulation-pre-stimulation)/(stimulation + pre-stimulation)
EEG power in spectral frequency bands
Time frame: During the trial(up to 3 hours for each subject)
Using SEEG-implanted electrodes, the investigators applied electrical stimulation single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods. EEG Frequency Bands delta (1-4 Hz) theta (5-8 Hz) alpha (9-12 Hz) beta (13-30 Hz) low gamma (31-70 Hz) high gamma (71-150 Hz)
Phase Locking Value
Time frame: During the trial(up to 3 hours for each subject)
To estimate functional connectivity through the oscillatory synchrony of two brain regions, phase locking value (PLV) provides a measure of inter-regional synchrony based on phase difference between the paired signals.
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 22 Jan 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 Single-pulse stimulation, Paired-pulse stimulation and Stepwise frequency stimulation in people with Epilepsy, 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 5 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 22 Jan 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 (+86 13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation Factor (time frame: During the trial(up to 3 hours for each subject)). The study lists 3 primary outcomes in all. 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 22 Jan 2025.