Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06898138
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Brain Interchange System — DEVICE
    The CorTec Brain Interchange (BIC) is an implantable system with sensing and stimulation capability dedicated to promoting brain computer interface and closed-loop neuromodulation research. It is an externally powered implant which can provide neural data to a nearby computing station (communication unit connected to a personal computer) continuously. In return, computing station controls the implant e.g. for generating therapeutic electrical stimulation to the brain. It is expected that BIC will catalyze translational applications of electroceuticals in human subject by making the neural data immediately available as well as permit the investigation of novel closed-loop neuromodulation applications.

Study Details

Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Feb 15, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Epilepsy
    Patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit

Primary Outcome Measure

Feasibility of Detection of Stereotyped HFOs [ Time Frame: Within the first 3 years of the project ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Chandra Prakash Swamy, M.S.
[email protected]
507-255-1516
Baylor College of MedicineHoustonTexas77030-3498
Alica Goldman, M.D., Ph.D.
[email protected]
713-798-0980

Find similar trials in Rochester, MN

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Mayo Clinic· Rochester, MNBaylor College of Medicine· Houston, TX

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