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NCT01415362 · ClinicalTrials.gov registry record · NA
Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
A NA study, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT01415362 is a NA study that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 6 participants.
The verdict
NCT01415362, a NA study, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Transcranial Direct Current Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01415362
The ClinicalTrials.gov registry entry for NCT01415362 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transcranial Direct Current Stimulation is the first listed.
NCT01415362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01415362 about?
NCT01415362 is a clinical study titled "Closed-loop 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 par...
What is the current status of trial NCT01415362?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2011-07. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01415362?
The interventions under investigation include: Transcranial Direct Current Stimulation (DEVICE).
Who is sponsoring clinical trial NCT01415362?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
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