About this trial
The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy
Informed consent
Disqualifiers
Lack of consent
Electrical or other devices that preclude the performance of an MRI for pre-operative imaging
Trial design
Single group
Treatments tested in this trial
Neuromodulation programming
DeviceParticipants will be brought in for their standard follow-up appointments at 4-weeks, 4-months, and 1-year post-surgery. In addition to the routine care, physiological data will be extracted from the implanted device and analyzed. The physiological data will be considered along with the standard epilepsy diary to assess epileptic burden and inform device programming. Quality of life will be measured with a series of standard questionnaires pre-surgery and at the 1-year follow-up.
Treatment groups
Trial outcomes
Primary outcomes
Seizure reduction
The number of seizures experienced by patients will be assessed by the number of seizures recorded by patients and their caregivers in seizure diaries and described as absolute seizure reduction.
Secondary outcomes
Change in disease score on Patient Weighted Quality Of Life In Epilepsy
Assessment of therapeutic effects using Patient Weighted Quality Of Life In Epilepsy, a 10-question survey completed by patients to assess quality of life, where a higher score is associated with a more positive quality of life.
Change in depression score on Neurological Disorders Depression Inventory in Epilepsy
Assessment of therapeutic effects using Neurological Disorders Depression Inventory in Epilepsy, a 6-question survey to assess depression. A higher score is associated with more severe depression.
Change in anxiety score on Anxiety General Anxiety Disorder-7
Assessment of therapeutic effects using Anxiety General Anxiety Disorder-7, a 7-question survey to assess anxiety. A higher score is associated with more severe anxiety, and a lower score is associated with minimal anxiety.
Sponsors and contacts
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