Motor EpilepsyCoSMosNCT07458217
Combined CM and STN Stimulation for Motor Epilepsy
A study testing Deep brain stimulation in people with Motor Epilepsy, run by Boston Scientific Corporation at 1 site in China.
Trial summary
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motor Epilepsy
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2026to 31 May 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 18-65 Years.
- 2) Drug Resistant Epilepsy.
- 3) Motor Epilepsy - defined as:
- Epilepsy diagnosis meeting ILAE criteria
- Motor Epilepsy defined as including one or more of:
- Tonic, Clonic, or Tonic-Clonic activity; ii. Myoclonic Jerks; iii.Epileptic Spasms; iv.Focal Motor Seizures (identified primary lesion will be in motor functional area, such as primary motor cortex (BA4), pre-motor cortex (BA6), Central Posterior Gyrus (BA1-3), or other motor region); v.Motor activity not secondary to non-motor seizure. c.Clinical or Electrographic corroboration of at least one of: i.Video-EEG confirmation of motor seizure semiology; ii.Interictal or ictal EEG findings consistent with epileptic motor network involvement; iii.Consistent clinical description by trained cliniciants.
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- 4) >3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days.
- 5) Subject or caregiver is able to provide epileptic seizure record within 90 days prior to the surgery.
- 6) Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.
Who cannot join
- 1) Non Motor Epilepsy.
- 2) Previous diagnosis of psychogenic/non-epileptic seizures.
- 3) Brain lesion resection or ablation surgery performed less than 6 months.
- 4) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device.
- 5) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).
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 Univers
Beijing, Beijing Municipality, 100053
CuiBai Wei, +86 010 83922345, wcb2024@xwhosp.org
Yongzhi Shan, PHD
About this study
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.
- Conditions
- Motor Epilepsy
- Being tested
- Deep brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
The DBS system is intended for patients with drug resistant motor epilepsy
| Study group | Role | What they receive |
|---|---|---|
| CM group | Active comparator | Not described Receives: Device: Deep brain stimulation |
| CM + STN group | Experimental | Not described Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in seizure frequency
Measured: Baseline to after 3 month CM and CM+STN stimulation.
Adverse events related to DBS implantation
Measured: After Device Inplanted to 12 month followup visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start13 Oct 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor EpilepsyStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458217
- Sponsor's protocol ID
- A4118
- Acronym
- CoSMos
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined CM and STN Stimulation for Motor Epilepsy
- ClinicalTrials.gov ID
- NCT07458217
- Acronym / sponsor ID
- CoSMos / A4118
- Conditions
- Motor Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Mar 2026 (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 self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM group | Active comparator | Device: Deep brain stimulation |
| CM + STN group | Experimental | Device: Deep brain stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) 18-65 Years.
- 2) Drug Resistant Epilepsy.
- 3) Motor Epilepsy - defined as:
- 4) >3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days.
- 5) Subject or caregiver is able to provide epileptic seizure record within 90 days prior to the surgery.
Key exclusion criteria (5 listed)
- 1) Non Motor Epilepsy.
- 2) Previous diagnosis of psychogenic/non-epileptic seizures.
- 3) Brain lesion resection or ablation surgery performed less than 6 months.
- 4) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device.
- 5) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).
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 |
|---|---|---|
| Deep brain stimulationThe DBS system is intended for patients with drug resistant motor epilepsy | Device | CM + STN group, CM group |
Primary outcome
Mean change in seizure frequency
Time frame: Baseline to after 3 month CM and CM+STN stimulation.
Adverse events related to DBS implantation
Time frame: After Device Inplanted to 12 month followup visit.
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 30 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Motor Epilepsy, run by Boston Scientific Corporation 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 9 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 30 Oct 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in seizure frequency (time frame: Baseline to after 3 month CM and CM+STN stimulation.). The study lists 2 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 30 Oct 2026.