Status:
COMPLETED
Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01415362
Start Date
July 1 2011
End Date
July 1 2014
Last Update
April 24 2020
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114