Ireland
--:--IST
Recruiting Not applicable

Combined CM and STN Stimulation for Motor Epilepsy

NCT07458217 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-10-13
Last updated
2026-10-30

Condition(s) studied

Motor Epilepsy

Investigational drug(s) / intervention(s)

Deep brain stimulation

Deep brain stimulation: The DBS system is intended for patients with drug resistant motor epilepsy

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Mean change in seizure frequency — Baseline to after 3 month CM and CM+STN stimulation.
  • Adverse events related to DBS implantation — After Device Inplanted to 12 month followup visit.

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital Capital Medical Univers Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07458217 on ClinicalTrials.gov ↗ ← All trials in China