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NCT Number: NCT07458217

Combined CM and STN Stimulation for Motor Epilepsy

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

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).

Treatment and study plan

Deep brain stimulation

Device

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

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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: CoSMos

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 9, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.