Clinical trial NCT06424977: Biomarker Targeted Stimulation for Epileptiform Events
Official title: Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Cadence Neuroscience
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 40
Sex: MALE
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.


Eligibility criteria: Inclusion Criteria:

1. Subject is greater than or equal to 7 years of age.
2. Subject has focal onset seizures.
3. Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
4. Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
5. Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
6. For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least three primary, disabling seizures per month, on average. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
7. Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
8. A female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the INSR, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal.
9. Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
10. Subject has had a brain MRI epilepsy evaluation within the past two years.
11. Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.

Exclusion Criteria:

1. Subject has a history of substance abuse within the preceding two years.
2. Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
3. Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS System or with which the BTS System interferes. Patients with a vagus nerve stimulator (VNS) implanted may be enrolled, provided their clinical status has been stable for at least one month prior to enrollment at their current stimulation parameter settings.
4. Subject has anatomy that may interfere with electrode placement.
5. Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
6. 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.
7. Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
8. Subject is ineligible for cranial surgery.

Primary outcomes:
measure: Adverse event rate
timeFrame: Intervals through 7, 12, and 24 months post-implant
Secondary outcomes:
measure: Seizure frequency
timeFrame: Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.
measure: Neurocognitive testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Depression testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Anxiety testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Quality of life testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Sleep testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Seizure severity testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
measure: Caregiver burden testing
timeFrame: Evaluated at 7 months, 12 months, and 24 months post-implant.
Other outcomes:
Locations:
Study officials:
References:
citation: Lundstrom BN, Worrell GA, Stead M, Van Gompel JJ. Chronic subthreshold cortical stimulation: a therapeutic and potentially restorative therapy for focal epilepsy. Expert Rev Neurother. 2017 Jul;17(7):661-666. doi: 10.1080/14737175.2017.1331129. Epub 2017 May 25.
citation: Kerezoudis P, Grewal SS, Stead M, Lundstrom BN, Britton JW, Shin C, Cascino GD, Brinkmann BH, Worrell GA, Van Gompel JJ. Chronic subthreshold cortical stimulation for adult drug-resistant focal epilepsy: safety, feasibility, and technique. J Neurosurg. 2018 Aug;129(2):533-543. doi: 10.3171/2017.5.JNS163134. Epub 2017 Oct 20.
citation: Lundstrom BN, Gompel JV, Khadjevand F, Worrell G, Stead M. Chronic subthreshold cortical stimulation and stimulation-related EEG biomarkers for focal epilepsy. Brain Commun. 2019;1(1):fcz010. doi: 10.1093/braincomms/fcz010. Epub 2019 Sep 6.
citation: Starnes K, Miller K, Wong-Kisiel L, Lundstrom BN. A Review of Neurostimulation for Epilepsy in Pediatrics. Brain Sci. 2019 Oct 18;9(10):283. doi: 10.3390/brainsci9100283.
citation: Alcala-Zermeno JL, Gregg NM, Van Gompel JJ, Stead M, Worrell GA, Lundstrom BN. Cortical and thalamic electrode implant followed by temporary continuous subthreshold stimulation yields long-term seizure freedom: A case report. Epilepsy Behav Rep. 2020 Sep 2;14:100390. doi: 10.1016/j.ebr.2020.100390. eCollection 2020.