Biomarker Targeted Stimulation for Epileptiform Events

Sponsor
Cadence Neuroscience
Study ID
NCT06424977
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Feb 14, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment

Primary Outcome Measure

Adverse event rate [ Time Frame: Intervals through 7, 12, and 24 months post-implant ]

Central Contacts

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