Biomarker Targeted Stimulation for Epileptiform Events (BTSEE)

May 14, 2026 updated by: Cadence Neuroscience

Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: Intervals through 7, 12, and 24 months post-implant
Determine adverse event rate, including adverse device effects and serious adverse events
Intervals through 7, 12, and 24 months post-implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seizure frequency
Time Frame: Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.
Using seizure diaries, calculate disabling seizure frequency, normalized to months, compared to baseline.
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.
Neurocognitive tests, using the NIH Toolbox, including the Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, and Picture Vocabulary Test, compared to baseline.
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.
Patient reported depression evaluation using Child Depression Inventory (CDI) or Beck Depression Inventory (BDI) (depending on age), compared to baseline.
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.
Patient reported anxiety evaluation using Revised Children's Manifest Anxiety Scale (RCMAS-2) or Beck Anxiety Inventory (depending on age), compared to baseline.
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.
Patient reported quality of life evaluation using Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55), Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48), or Quality of Life in Epilepsy (QOLIE-31) (depending on age), compared to baseline.
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.
Patient reported sleep evaluation using Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) or Epworth Sleepiness Scale (ESS) (depending on age), compared to baseline.
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.
Patient reported seizure severity evaluation using Liverpool Seizure Severity Scale 2.0 (LSSS 2.0), compared to baseline.
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.
Caregiver reported burden evaluation using Caregiver Burden Inventory (CBI), compared to baseline.
Evaluated at 7 months, 12 months, and 24 months post-implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cadence Neuroscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAD2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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