EpilepsyBTSEENCT06424977
Biomarker Targeted Stimulation for Epileptiform Events
A study testing Biomarker Targeted Stimulation (BTS) in people with Epilepsy, run by Cadence Neuroscience.
Trial summary
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System. Read more about this study
- Who is it for?
- Ages 7 years and older, men only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Biomarker Targeted Stimulation (BTS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
- Conditions
- Epilepsy
- Being tested
- Biomarker Targeted Stimulation (BTS)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Targeted Stimulation (BTS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Biomarker Targeted Stimulation (BTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
Determine adverse event rate, including adverse device effects and serious adverse events
Measured: Intervals through 7, 12, and 24 months post-implant
Secondary outcomes (8)
Seizure frequency
Using seizure diaries, calculate disabling seizure frequency, normalized to months, compared to baseline.
Measured: Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.
Neurocognitive testing
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.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Depression testing
Patient reported depression evaluation using Child Depression Inventory (CDI) or Beck Depression Inventory (BDI) (depending on age), compared to baseline.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Anxiety testing
Patient reported anxiety evaluation using Revised Children's Manifest Anxiety Scale (RCMAS-2) or Beck Anxiety Inventory (depending on age), compared to baseline.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Quality of life testing
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.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Sleep testing
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.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Seizure severity testing
Patient reported seizure severity evaluation using Liverpool Seizure Severity Scale 2.0 (LSSS 2.0), compared to baseline.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Caregiver burden testing
Caregiver reported burden evaluation using Caregiver Burden Inventory (CBI), compared to baseline.
Measured: Evaluated at 7 months, 12 months, and 24 months post-implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cadence Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424977
- Sponsor's protocol ID
- CAD2004
- Acronym
- BTSEE
- Status last verified
- Oct 2026
- First submitted
- 9 May 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 28532252Kerezoudis 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.
PubMed 29053073Lundstrom 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.
PubMed 31667473Starnes 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.
PubMed 31635298Alcala-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.
PubMed 32995742
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy
- ClinicalTrials.gov ID
- NCT06424977
- Acronym / sponsor ID
- BTSEE / CAD2004
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cadence NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Biomarker Targeted Stimulation (BTS) |
Who may qualify
- Ages
- 7 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment |
Primary outcome
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
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 28532252Lundstrom 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.
- Background: PubMed 29053073Kerezoudis 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.
- Background: PubMed 31667473Lundstrom 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.
- Background: PubMed 31635298Starnes 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.
- Background: PubMed 32995742Alcala-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.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker Targeted Stimulation (BTS) in people with Epilepsy, run by Cadence Neuroscience.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Himes, BSEE (425-679-9505, dhimes@cadenceneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: Intervals through 7, 12, and 24 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424977, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.