Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
- Conditions
- EpilepsySeizures
- Interventions
- Device: Transcranial Direct Current Stimulation
- Registration Number
- NCT01415362
- Lead Sponsor
- Spaulding Rehabilitation Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active tDCS Transcranial Direct Current Stimulation The subject will receive sessions of active tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period. Sham tDCS Transcranial Direct Current Stimulation The subject will receive sessions of sham tDCS remotely triggered by the EEG monitoring system each time seizure activity is detected during the 24-hour period.
- Primary Outcome Measures
Name Time Method Measurement of seizure activity via electroencephalography (EEG) Measured for approximately 48 hours Measurement of seizure activity will take place in two visits of 24-hour seizure monitoring. During these visits, the EEG will record seizure information including (1) number of seizures, (2) severity of seizures, and (3) latency of seizures between sessions of stimulation.
- Secondary Outcome Measures
Name Time Method Subject self-report of seizure activity Measured for approximately 8 weeks. Subject will keep a diary to monitor baseline seizure activity between study visits. This will be measured daily for the 8 weeks the subject will participate.
N-back memory and attention test Measured for approximately 2 hours We will assess working memory and attention in healthy individuals using the n-back test, assessing changes from pre- to post-tDCS
Measurement of healthy subjects EEG changes Measured for approximately 2 hours We will compare changes in EEG from before stimulation to after stimulation in a healthy cohort. We will test the system to trigger in healthy subjects when there is an increase of beta frequency power and decrease of alpha frequency power. We will also assess whether the tDCS stimulation will return the background EEG rhythm toward a baseline pattern (increasing alpha, decreasing beta)
Trial Locations
- Locations (1)
Spaulding Rehabilitation Hospital
🇺🇸Boston, Massachusetts, United States