Epilepsy, Drug ResistantNCT06663124
Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
A study testing EC-DBS ON in people with Epilepsy, Drug Resistant, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Epilepsy, Drug Resistant
- What is being tested?
- EC-DBS ON
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants are between the ages of 14 -65 years of age
- Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
- Persistence of disabling seizures at least 3 times per month or greater,
- Informed consent signed.
Who cannot join
- Structural alterations are present in the extreme capsule.
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- IQ < 55 or severe cognitive dysfunction, unable to complete the study;
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- Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
- Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
- Pregnant, or planning to pregnant within 2 years;
- Participation in another clinical study within 3 months;
- Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
Liankun Ren
About this study
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy
Read the detailed description
This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application
- Conditions
- Epilepsy, Drug Resistant
- Being tested
- EC-DBS ON
- Keywords
- Extreme capsule, Deep Brain Stimulation, Drug Resistant Epilepsy, Focal Epilepsy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-DBS ONDevice
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are extreme capsule.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.
| Study group | Role | What they receive |
|---|---|---|
| EC-DBS group | Experimental | participants will undergo EC-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. Receives: Device: EC-DBS ON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:
SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
Measured: Up to 1 year after EC-DBS
Secondary outcomes (4)
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Measured: Up to 1 year after EC-DBS
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
Measured: Up to 1 year after EC-DBS
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Measured: Up to 1 year after EC-DBS
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow
Measured: Up to 1 year after EC-DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Drug ResistantStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06663124
- Sponsor's protocol ID
- 2023-083
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT06663124
- Acronym / sponsor ID
- 2023-083
- Conditions
- Epilepsy, Drug Resistant
- Keywords
- Extreme capsule, Deep Brain Stimulation, Drug Resistant Epilepsy, Focal Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 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.
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy
Detailed description
This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EC-DBS group | Experimental | Device: EC-DBS ONparticipants will undergo EC-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
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)
- Participants are between the ages of 14 -65 years of age
- Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
- Persistence of disabling seizures at least 3 times per month or greater,
- Informed consent signed.
Key exclusion criteria (12 listed)
- Structural alterations are present in the extreme capsule.
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
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 |
|---|---|---|
| EC-DBS ONThe surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are extreme capsule.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist. | Device | EC-DBS group |
Primary outcome
Seizure frequency (SF28)
Time frame: Up to 1 year after EC-DBS
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
4 secondary outcomes
Seizure Responder Rate
Time frame: Up to 1 year after EC-DBS
Life quality evaluation
Time frame: Up to 1 year after EC-DBS
Adverse Events
Time frame: Up to 1 year after EC-DBS
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
Time frame: Up to 1 year after EC-DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 EC-DBS ON in people with Epilepsy, Drug Resistant, 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 12 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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. 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?
Results are not available in the source record.
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?
Seizure frequency (SF28) (time frame: Up to 1 year after EC-DBS). 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 29 Oct 2024.