Menu
Not yet recruiting NCT06424977

Biomarker Targeted Stimulation for Epileptiform Events

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biomarker Targeted Stimulation (BTS).
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: from 7 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy

Overview

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

Interventions

  • Device Biomarker Targeted Stimulation (BTS)
    Using continuous stimulation to target multiple network nodes, Biomarker Targeted Stimulation (BTS) is intended to suppress abnormal interictal activity, as determined by biomarkers including interictal epileptiform discharges (IED) and high frequency oscillations (HFO), with the intention to reduce brain hyperexcitability, thereby limiting seizure occurrence.

Primary outcome measures

  • Adverse event rate [Time frame: Intervals through 7, 12, and 24 months post-implant]
Secondary outcome measures (8)
  • Seizure frequency [Time frame: Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.]
  • Neurocognitive testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Depression testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Anxiety testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Quality of life testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Sleep testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Seizure severity testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]
  • Caregiver burden testing [Time frame: Evaluated at 7 months, 12 months, and 24 months post-implant.]

Eligibility criteria

Inclusion criteria

  • Subject is greater than or equal to 7 years of age.
  • Subject has focal onset seizures.
  • Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
  • Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
  • Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
  • 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.
  • Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
  • 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.
  • Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
  • Subject has had a brain MRI epilepsy evaluation within the past two years.
  • Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.

Exclusion criteria

  • Subject has a history of substance abuse within the preceding two years.
  • Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
  • 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.
  • Subject has anatomy that may interfere with electrode placement.
  • Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
  • 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.
  • Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
  • Subject is ineligible for cranial surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 28532252
  • 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. PMID 29053073
  • 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. PMID 31667473
  • 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. PMID 31635298
  • 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. PMID 32995742

Identifiers

NCT: NCT06424977 · CAD2004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗