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RecruitingNCT07458217CoSMosUpdated Oct 30, 2026

Combined CM and STN Stimulation for Motor Epilepsy

An interventional study of Deep brain stimulation in Motor Epilepsy, sponsored by Boston Scientific Corporation. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Now RecruitingFirst site in China+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Motor Epilepsy

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03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Browse Boston Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1) 18-65 Years.
  • 2) Drug Resistant Epilepsy.

  • 3) Motor Epilepsy - defined as:

    1. Epilepsy diagnosis meeting ILAE criteria
    2. Motor Epilepsy defined as including one or more of:

    i. 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.

  • 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 form, and be willing to comply with study requirements, including follow-ups.

Exclusion criteria

Exclusion Criteria:

  • 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 ).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    CM group

    Device: Deep brain stimulation

  • Experimental
    CM + STN group

    Device: Deep brain stimulation

Interventions

  • DeviceDeep brain stimulation

    The DBS system is intended for patients with drug resistant motor epilepsy

06

What researchers measure

Primary outcomes

  1. Mean change in seizure frequency

    Time frame: Baseline to after 3 month CM and CM+STN stimulation.

  2. Adverse events related to DBS implantation

    Time frame: After Device Inplanted to 12 month followup visit.

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital Capital Medical Univers
    Beijing, Beijing Municipality 100053, China
    Recruiting
    • CuiBai Wei · Contactwcb2024@xwhosp.org · +86 010 83922345
    • Yongzhi Shan, PHD · Principal investigator
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for May 2028, 19 months after the start.

Of 358 interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's planned 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2026
First posted
Mar 9, 2026
StartActual
Oct 13, 2026
Primary completionEst.
May 31, 2028
CompletionEst.
May 31, 2028
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 30, 2026
Sites
1 site added — first site in China
Show site
  • Xuanwu Hospital Capital Medical Univers · Beijing, China
Oct 30, 2026
Start date
Oct 31, 2026→Oct 13, 2026 (actual)
Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in China
    Show site
    • Xuanwu Hospital Capital Medical Univers · Beijing, China
    Start date Oct 31, 2026→Oct 13, 2026 (now actual)
    + 1 other change: verification date
  2. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07458217
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Oct 13, 2026
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Oct 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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