Combined CM and STN Stimulation for Motor Epilepsy (CoSMos)

May 23, 2026 updated by: Boston Scientific Corporation
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 childbearing potential).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CM group
Device: Deep brain stimulation
The DBS system is intended for patients with drug resistant motor epilepsy
Experimental: CM + STN group
Device: Deep brain stimulation
The DBS system is intended for patients with drug resistant motor epilepsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in seizure frequency
Time Frame: Baseline to after 3 month CM and CM+STN stimulation.
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.
After Device Inplanted to 12 month followup visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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