Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | July 2011 |
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.
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.
Inclusion Criteria (Epileptics)
- Disabling motor simple partial seizures, complex partial seizures, and/or secondarily
generalized seizures. Disabling refers to seizures that are severe enough to
significantly impair functional abilities in areas such as employment, psychological
or social wellbeing, education or mobility.
- Failed treatment with a minimum of two antiepileptic medications.
- Experienced an average of three or more disabling simple weekly partial seizures,
complex partial seizures and/or secondarily generalized seizures.
- Between the ages of 18 and 70 years.
- No more than two epileptogenic regions in the brain.
- Must be able to provide informed consent themselves.
Exclusion Criteria
- 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
We found this trial at
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Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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