Motor Epilepsy
Conditions
Brief 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.
Interventions
DEVICEDeep brain stimulation
The DBS system is intended for patients with drug resistant motor epilepsy
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed