Biomarker Targeted Stimulation for Epileptiform Events
NCT06424977 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-18
Summary
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
Conditions
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.
Sponsors & Collaborators
-
Cadence Neuroscience
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2028-09-01
- Completion
- 2030-02-14
- FDA Device
- Yes
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