Stimulation of the Thalamus for Arousal Restoral in Temporal Lobe Epilepsy (NCT04897776) | Clinical Trial Compass
CompletedNot Applicable
Stimulation of the Thalamus for Arousal Restoral in Temporal Lobe Epilepsy
United States5 participantsStarted 2021-10-31
Plain-language summary
The goal is to provide a novel therapeutic option for temporal lobe epilepsy patients when focal impaired awareness seizures cannot be stopped by medications, surgical or laser ablation, or by neurostimulation. The goal is restore consciousness when seizures cannot be stopped. If successful, addition of bilateral thalamic stimulation to existing responsive neurostimulation to rescue consciousness would greatly alter clinical practice and patient outcomes.
Importantly, previous approaches aim to stop seizures, whereas this study aims to use thalamic stimulation to improve a major negative consequence when seizures cannot be stopped. The potential impact extends beyond temporal lobe epilepsy to other seizure types, and may also extend more broadly to inform treatment of other brain disorders associated with impaired consciousness and cognition.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. All patients will have evidence of mesial temporal seizures based on either
✓. Intracranial EEG monitoring with mesial temporal lobe onset
✓. or scalp EEG evidence of temporal lobe seizures and other evidence of mesial temporal lobe epilepsy.
✓. Subject's seizure focus, based upon clinical history, semiology, electroencephalographic (EEG) findings, and/or neuroimaging, shall demonstrate bilateral or unilateral mesial temporal lobe epilepsy, and subject shall not be good candidate for surgical resection.
✓. Focal epilepsy with disabling seizure counts mean of ≥ 2 per month. Disabling seizures are those with significant negative impact on the patient's life, involving impaired conscious awareness. Seizures counts will be based on patient's self-report. Note that patient's typically have more disabling seizures than they are able to self-report, and may also have additional non-disabling seizures in addition to the disabling seizures required for enrolment.
✓. Drug resistance to at least two antiseizure medications (ASM) with adequate dose and duration.
✓. Subject is willing to remain on stable ASM from the Baseline phase through the end of the Randomized CL Stimulation phase. Stable is defined as same medications, but dose adjustments are allowed within accepted therapeutic ranges. Also, short-term benzodiazepines allowed for acute seizure worsening as in prior studies.
✓. Apart from epilepsy, subject must be medically and neurologically stable and must have no other medical condition in the opinion of the treating physician that would preclude the patient from participation. This could include conditions like severe ischemic cardiac disease, progressive dementia or other disorders that could affect surgical eligibility or compliance.
Exclusion criteria
✕. Subject has a contraindication to magnetic resonance imaging.
✕. Subject has a significant substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years with evidence of impact on daily function.
✕. Subject participated in another drug or device trial within the preceding 30 days.
✕. Demonstrates that they fulfill criteria on any of the three subscale of the SCID-5-PD for borderline, antisocial, or narcissistic personality disorders and these criteria are then corroborated by psychiatric interview, and that this would significantly affect participation in the study.
✕. Suicide attempt in the past year.
✕. Arrest for assault or possession of drugs or weapons with intent to sell/distribute in the past year.
✕. Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the RC+S device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, vagus nerve stimulators (VNS), and cochlear implants. Patients with a vagus nerve stimulator implanted but turned off through the duration of the study may be enrolled, provided their clinical status has been stable for at least one month with VNS turned off. Alternatively, patients with a VNS may have the previously disabled VNS removed at time of surgery to implant the Medtronic RC+S.
✕. Subject has confirmed active diagnosis of psychogenic or non-epileptic seizures.