Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
Completed · Not applicable · Has a placebo group
Conditions studied: Epilepsy, Seizures
In brief
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.
Key facts
- Study ID
- NCT01415362
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 6
- Starts
- 2011-07-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2020-04-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Has a progressive neurological or systemic disease.
- Has a history of nonepileptic seizures.
- Has an implanted metallic device, aneurysm clips, cochlear implants, or spinal cord stimulator.
- Has suffered a severe traumatic brain injury with skull fracture.
- Contraindications to tDCS
- metal in the head
- implanted brain medical devices
- Pregnancy
- Any implanted electrical medical device, including pacers and implanted cardiac defibrillators
- Inclusion criteria (Healthy Subjects)
- Healthy subjects age 18 and older
- Exclusion criteria:
- Existence of major neurologic or psychiatric condition (i.e. epilepsy, severe depression)
- History of head injury resulting in more than a momentary loss of consciousness
- Previous neurosurgery
- A history of significant alcohol or drug abuse in the prior 6 months
- Presence of unstable medical conditions, such as; uncontrolled diabetes mellitus, cardiac pathology, cancer, kidney insufficiency, acute thrombosis
- Contraindication to tDCS
- metal in the head
- implanted electronic medical devices
- Pregnancy
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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