Epilepsy, Drug ResistantSTEMNCT06248333
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
A study testing STN-DBS ON and STN-DBS OFF in people with Epilepsy, Drug Resistant, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor 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?
- STN-DBS ON and STN-DBS OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2024to 30 Jun 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
- 14-65 years of age, inclusive, at Screening Visit.
- Refractory to anti-seizure medications (ASMs).
- Diagnosed with focal motor epilepsy, which meets the following items:
- Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral tonic-clonic seizure.
- After a comprehensive evaluation, the epileptogenic zone was presumed to predominantly involve the unilateral or bilateral central area (precentral gyrus, postcentral gyrus, and paracentral lobule) or supplementary motor area according to comprehensive presurgical evaluation.
- Within 1 month prior to the Screening Visit (M-3), the following conditions are met:
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- At least 3 focal onset seizures (with or without secondary bilateral tonic-clonic seizure).
- Subject is receiving at least one type of ASM[s], and the regimen has been stable (no addition or removal of ASM[s] [not counting brief rescue medicines such as benzodiazepines]; dose adjustments are permitted to ASM[s]).
- Within the baseline period (3 months after the Screening Visit [M-3]), the following conditions are met:
- The patient or their caregiver is capable of completing the seizure diary.
- Seizure diary shows an average of 3 or more partial-onset seizures (with or without secondary bilateral tonic-clonic seizure) per month during the Baseline Period, with no more than 30 days between seizures.
- The regimen of ASM[s] has been stable (no addition or removal of ASM[s] [not counting brief rescue medicines such as benzodiazepines]; dose adjustments are permitted to ASM[s]).
- After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
- Informed consent signed.
Who cannot join
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.);
- Tonic-clonic status epilepticus within12 months;
- Psychogenic non-epileptic seizures within 12 months;
- Structural lesion of the subthalamic nucleus;
- 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;
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- 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;
- 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. 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
Official title: Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor epilepsy.
Read the detailed description
This is a multicenter, randomized, double-blind, sham-controlled, parallel-group trial that aims to investigate the efficacy of STN-DBS in reducing the frequency of seizures in drug-resistant focal motor epilepsy. Participants who were eligible for the inclusion criteria and ineligible for the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. The primary purpose of this study is to compare active STN-DBS with sham STN-DBS in reducing seizure frequency. Both intent analysis (ITT) and compliance program set (PPS) were used for analysis. Only high-volume centers with a proven track record will be included. The STEM trial will be conducted in 5 sites in China.
- Conditions
- Epilepsy, Drug Resistant
- Being tested
- STN-DBS ON, STN-DBS OFF
- Keywords
- Deep Brain Stimulation, Drug Resistant Epilepsy, Subthalamic Nucleus, Focal Motor Epilepsy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Partial, Motor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-DBS ONDevice
Stimulation ON
STN-DBS OFFDevice
Stimulation OFF
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | After randomization, participants will undergo STN-DBS ON in the 3-month blinded phase (Month 2 to Month 5) with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. Receives: Device: STN-DBS ON |
| Sham Stimulation | Sham comparator | After randomization, participants will undergo STN-DBS OFF in the 3-month blinded phase (Month 2 to Month 5) with 0mA current, then the stimulator will be turned on with individual stimulation parameters and left on for the remainder of the study. Receives: Device: STN-DBS OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Percent Change in Seizure Frequency
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: Through the end of the three-month blinded phase
Secondary outcomes (13)
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Measured: Through the end of the three-month blinded phase
Seizure Severity
The percent change from baseline in seizure severity evaluated by Liverpool seizure severity scale (LSSS) across the double-blind period.
Measured: Through the end of the three-month blinded phase
Seizure-free Days
Change in percentage of seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.
Measured: Through the end of the three-month blinded phase
The maximum length of seizure-free Intervals
Percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.
Measured: Through the end of the three-month blinded phase
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Motor function evaluation
Percentage change from baseline in Unified Parkinson's Disease Rating Scale part II \& part III (UPDRS II-III) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Cognitive function evaluation (MMSE)
Percentage change from baseline in Mini-Mental State Examination (MMSE) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Cognitive function evaluation (MoCA)
Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Psychologic Evaluation (Anxiety)
Percentage change from baseline in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Psychologic Evaluation (Depression)
Percentage change from baseline in Hamilton Depression Rating Scale (HAMD) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Sleep Quality
Percentage change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 3 months after randomization.
Measured: Through the end of the three-month blinded phase
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Measured: Through Month 11 of the open-label follow-up phase
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-up.
Measured: Through Month 11 of the open-label follow-up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start14 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- After completion of DBS surgery (Month 0), participants will undergo an 8-day parameter exploration period after 1-month postoperative recovery (month 1), and DBS off after individual parameters have been determined. At Month 2, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (Activate Stimulation) will have their stimulator turned on after randomization. Group B (Sham Stimulation) will receive sham stimulation, meaning the stimulator will remain off until Study Month 5. At Month 5, Group A will continue to receive stimulation and not have the stimulator turned off, and the stimulator in Group B will be turned on and left on for the remainder of the study (Month 11).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Sanbo Brain Hospital, Qilu Hospital of Shandong University, Peking University
- 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
- NCT06248333
- Sponsor's protocol ID
- 2023-174-002
- Acronym
- STEM
- Status last verified
- Jul 2025
- First submitted
- 14 Jan 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT06248333
- Acronym / sponsor ID
- STEM / 2023-174-002
- Conditions
- Epilepsy, Drug Resistant
- Keywords
- Deep Brain Stimulation, Drug Resistant Epilepsy, Subthalamic Nucleus, Focal Motor Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Sanbo Brain Hospital, Qilu Hospital of Shandong University, Peking University
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Feb 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 primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor epilepsy.
Detailed description
This is a multicenter, randomized, double-blind, sham-controlled, parallel-group trial that aims to investigate the efficacy of STN-DBS in reducing the frequency of seizures in drug-resistant focal motor epilepsy. Participants who were eligible for the inclusion criteria and ineligible for the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. The primary purpose of this study is to compare active STN-DBS with sham STN-DBS in reducing seizure frequency. Both intent analysis (ITT) and compliance program set (PPS) were used for analysis. Only high-volume centers with a proven track record will be included. The STEM trial will be conducted in 5 sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After completion of DBS surgery (Month 0), participants will undergo an 8-day parameter exploration period after 1-month postoperative recovery (month 1), and DBS off after individual parameters have been determined. At Month 2, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (Activate Stimulation) will have their stimulator turned on after randomization. Group B (Sham Stimulation) will receive sham stimulation, meaning the stimulator will remain off until Study Month 5. At Month 5, Group A will continue to receive stimulation and not have the stimulator turned off, and the stimulator in Group B will be turned on and left on for the remainder of the study (Month 11).
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: STN-DBS ONAfter randomization, participants will undergo STN-DBS ON in the 3-month blinded phase (Month 2 to Month 5) with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
| Sham Stimulation | Sham comparator | Device: STN-DBS OFFAfter randomization, participants will undergo STN-DBS OFF in the 3-month blinded phase (Month 2 to Month 5) with 0mA current, then the stimulator will be turned on with individual stimulation parameters and left on 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 (14 listed)
- 14-65 years of age, inclusive, at Screening Visit.
- Refractory to anti-seizure medications (ASMs).
- Diagnosed with focal motor epilepsy, which meets the following items:
- Within 1 month prior to the Screening Visit (M-3), the following conditions are met:
- Within the baseline period (3 months after the Screening Visit [M-3]), the following conditions are met:
Key exclusion criteria (14 listed)
- Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.);
- Tonic-clonic status epilepticus within12 months;
- Psychogenic non-epileptic seizures within 12 months;
- Structural lesion of the subthalamic nucleus;
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 |
|---|---|---|
| STN-DBS ONStimulation ON | Device | Active Stimulation |
| STN-DBS OFFStimulation OFF | Device | Sham Stimulation |
Primary outcome
Median Percent Change in Seizure Frequency
Time frame: Through the end of the three-month blinded phase
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.
13 secondary outcomes
Seizure Responder Rate
Time frame: Through the end of the three-month blinded phase
Seizure Severity
Time frame: Through the end of the three-month blinded phase
Seizure-free Days
Time frame: Through the end of the three-month blinded phase
The maximum length of seizure-free Intervals
Time frame: Through the end of the three-month blinded phase
Life quality evaluation
Time frame: Through the end of the three-month blinded phase
Motor function evaluation
Time frame: Through the end of the three-month blinded phase
Cognitive function evaluation (MMSE)
Time frame: Through the end of the three-month blinded phase
Cognitive function evaluation (MoCA)
Time frame: Through the end of the three-month blinded phase
Psychologic Evaluation (Anxiety)
Time frame: Through the end of the three-month blinded phase
Psychologic Evaluation (Depression)
Time frame: Through the end of the three-month blinded phase
Sleep Quality
Time frame: Through the end of the three-month blinded phase
Adverse Events
Time frame: Through Month 11 of the open-label follow-up phase
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
Time frame: Through Month 11 of the open-label follow-up phase
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 15 Jul 2025.
- 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.
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 STN-DBS ON and STN-DBS OFF 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 14 inclusion and 14 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 15 Jul 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. Some participants in this study may receive a placebo. 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?
Median Percent Change in Seizure Frequency (time frame: Through the end of the three-month blinded phase). 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 15 Jul 2025.