Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations for Epilepsy
This study is testing a new implantable device called the CorTec Brain Interchange (BIC) for people with epilepsy that doesn't respond well to medicine. The BIC system aims to prevent seizures by detecting specific brain signals called stereotyped high-frequency oscillations (HFOs) and then delivering targeted electrical stimulation. Unlike current devices that react after a seizure starts, the BIC system will try to stop seizures before they happen. This study will enroll 8 participants, aged 3 to 70 years, who have medically refractory epilepsy and are candidates for brain monitoring. Success for this study means showing that the BIC system can detect these HFOs and deliver stimulation effectively.
- Study design
- This is an interventional study with a planned enrollment of 8 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure feasibility of detecting HFOs within the first 3 years and feasibility of delivering stimulation in the 4th and 5th years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Feasibility of Detection of Stereotyped HFOsWithin the first 3 years of the project
Outcome-2 will test the feasibility of capturing stereotyped HFO (sHFO) with the BIC system in the EMU setting. Once the feasibility of robust data transmission as listed in (Outcome-1) is tested, the neural activity will be recorded over 24 hours using the BIC system from 10 patients. The hardware will not be implanted but used externally to record the neural data. Then, the research team will compare whether the sHFO detection and SOZ localization accuracy is significantly different between the BIC and FDA approved amplifier. If the investigators can detect stereotyped HFOs with a rate not less than 75% of FDA approved clinical amplifier and predict the SOZ in 8/10 patients, then the research team will move to the second phase of the project to test Outcome-3. Outcome-2 tests the feasibility of capturing relevant neural events with the external BIC system and compares the recording quality to the FDA approved amplifiers. Outcome-2 does not test any health-related outcome.
- Feasibility of Delivering Closed-Loop StimulationIn the 4th and 5th years of the project
Outcome-3 will test the feasibility of delivering of closed-loop stimulation with the BIC system. If the detection of sHFO with the BIC system is feasible (Outcome-2), the investigators will start to test the online methods on the previously recorded datasets to isolate sHFOs in streaming iEEG/ECoG. Using the computer in the loop real-time system and the BIC, in the last 2 years, closed-loop stimulation will be delivered. In total 8 patients will be recruited for this particular purpose. Targeted stimulation will be delivered to those channels associated with sHFOs and other areas which are not associated with sHFOs. The research team will test if the device can deliver stimulation to selected channels without any failure. The BIC system will not be implanted but used externally to deliver the stimulation. Outcome-3 does not test whether the system can control the seizures of the patients. It only investigates the feasibility of delivering closed-loop stimulation.