Combined CM and STN Stimulation for Motor Epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This self-crossover, randomized pilot trial explores bilateral deep brain stimulation of the centromedian thalamus and the subthalamic nucleus in adults with drug‑resistant motor epilepsy. Participants will have motor seizures and meet specific epilepsy criteria, with seizure types and frequencies recorded to compare outcomes. The study is led by a sponsor and conducted at a Beijing site, focusing on safety and preliminary efficacy signals. Data collected will inform feasibility of a larger, definitive trial. The design emphasizes patient safety and robust seizure documentation through standardized records.

Why it matters

Who can join: the full rules

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).

Where it's running

• Xuanwu Hospital Capital Medical Univers
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.