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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM group | Active Comparator |
| |
| CM + STN group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | The DBS system is intended for patients with drug resistant motor epilepsy |
|
| Measure | Description | 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. |
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Inclusion Criteria:
1) 18-65 Years.
2) Drug Resistant Epilepsy.
3) Motor Epilepsy - defined as:
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:
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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