Epilepsy Clinical Trial
Official title:
Development of a Closed-loop Detect-and-treat System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
In this pilot study, the researchers investigated the feasibility of a closed-loop
electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for
treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation
within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle
determination of whether tDCS applied during this vulnerable period may be feasible to
prevent the oncoming seizure.
This study required 5 visits over the course of approximately 8 weeks. Each visit was
separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During
these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when
seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects
received active stimulation or sham stimulation sessions during the first 24-hour visit, and
the opposite during the second. The subjects were randomized and counterbalanced.
We have also added a healthy subjects cohort to assess the feasibility of the closed loop
system. In order to test the proof-of-concept of this system, the experiment will focus on
detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is
being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6
subjects who will have 2 visits each. During these two visits subjects will be randomized to
active or sham stimulation sessions and receive the opposite during their second visit.
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