Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
1. All patients will have evidence of mesial temporal seizures based on either
1. Intracranial EEG monitoring with mesial temporal lobe onset
2. or scalp EEG evidence of temporal lobe seizures and other evidence of mesial
temporal lobe epilepsy.
2. 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.
3. 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.
i. Mean seizure count ≥ 2 per month is established initially for the preceding 6
months at time of Enrollment, using seizures reported by the patient and/or caregiver.
Seizures during EMU admissions are not included.
4. Drug resistance to at least two antiseizure medications (ASM) with adequate dose and
duration.
5. 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.
6. 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.
7. The local treating epilepsy center has recommended the patient for brain stimulation
therapy on clinical grounds and without reference to this protocol.
8. Age 18 to 75 years, inclusive, at time of consent.
9. Ability and willingness to provide informed consent and participate in the study
protocol.
10. Subject can interpret and to respond, in accordance with the study protocol, to the
advisory indicators provided by the device. This includes the ability to recharge the
device.
11. Subject has seizures that are distinct, stereotypical events that can be reliably
counted by the patient or caregiver.
12. Subject can reasonably be expected to maintain a seizure diary alone or with the
assistance of a competent individual.
13. Subject can complete regular office visits and telephone appointments in accordance
with the study protocol requirements.
14. A female subject must have a negative pregnancy test and if sexually active, must be
using a reliable form of birth control for the duration of the trial, be surgically
sterile, or be at least two years post-menopausal.
15. Subject has been informed of his or her eligibility for resective surgery as a
potential alternative to the study, if such surgery is a reasonable option.
16. Subject speaks and reads English.
17. Subject's anatomy will permit implantation of the Medtronic Investigational Summit
RC+S generator within 20 mm of the skin surface.
18. Subject is capable of completing the proposed neuropsychology evaluation and will
score no lower than 2 standard deviations below average on the Wechsler Adult
Intelligence Scale.
Exclusion Criteria:
1. Subject has a contraindication to magnetic resonance imaging.
2. Subject has a significant substance abuse history (alcohol, prescription, or illicit
medications) within the preceding two years with evidence of impact on daily function.
3. Subject participated in another drug or device trial within the preceding 30 days.
4. 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.
5. Suicide attempt in the past year.
6. Arrest for assault or possession of drugs or weapons with intent to sell/distribute in
the past year.
7. 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.
8. Subject has confirmed active diagnosis of psychogenic or non-epileptic seizures.
9. Subject has confirmed diagnosis of primary generalized seizures.
10. Subject has experienced unprovoked status epilepticus in the preceding year.
11. Subject has had therapeutic surgery to treat epilepsy that may interfere with
electrode placement.
12. Subject has progressive neurological disorder or medical condition that would prevent
the participant to fully participate in the clinical trial.
13. Subject has severe chronic pulmonary disease or cardiac disease, local, systemic acute
or chronic infectious illness.
14. Subject is on anticoagulants and is unable to discontinue them peri-surgically, as
required by the neurosurgeon or Investigator.
15. Subject has significant platelet dysfunction from medical conditions or medications
(including, particularly, aspirin or sodium valproate). If platelet dysfunction is
suspected, subject can be enrolled only if a hematologist, the Investigator, and the
neurosurgeon judge it to be advisable.
16. Subject is ineligible for cranial surgery.
17. Subject scores equal to or below a full-scale intelligence quotient (FSIQ) of 70, as
measured by the Wechsler Adult Intelligence Scale.
18. Pregnancy.
19. Any condition or finding that in the judgement of the site PI significantly increases
risk or significantly reduces the likelihood of benefit from participation in the
study.
Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.