Combined CM and STN Stimulation for Motor Epilepsy
ConditionMotor Epilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBoston Scientific Corporation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
1) 18-65 Years.
2) Drug Resistant Epilepsy.
Epilepsy diagnosis meeting ILAE criteria
4) >3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Deep brain stimulation
DeviceThe DBS system is intended for patients with drug resistant motor epilepsy
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: CM groupActive comparator 1 intervention
Group B: CM + STN groupExperimental treatment 1 intervention
Trial outcomes
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: