Status:
COMPLETED
High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
9-65 years
Phase:
PHASE1
Brief Summary
High-Definition transcranial Direct Current Stimulation (HD tDCS) Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be arranged on the skull according to a 4x1-r...
Detailed Description
1 Introduction This document is a protocol for a human research study. This study is to be conducted in accordance with US government research regulations, and applicable international standards of Go...
Eligibility Criteria
Inclusion
- Age 9 to 65 years
- Focal-onset neocortical epilepsy (as determined by semiology, EEG, and/or MRI)
- Frequent (\>50% of EEG record) focal epileptiform discharges on EEG and/or frequent (defined as average of ≥2 daily seizures) focal-onset clinical seizure, refractory to medical anti-epileptic treatment. For the purposes of this study, any patient who has been treated with three or more AEDs at therapeutic doses for at least four weeks per drug will be considered medically refractory.
- Seizure onset must be localizable by clinical semiology, EEG or MRI.
- Subjects or guardians must be competent to sign an informed consent indicating awareness of the investigational nature of this study, treatment, benefits and procedures involved.
Exclusion
- Age over 65 years or under 9 years.
- Implanted cardiac pacemakers, cochlear implants, implanted medication pump, or intracardiac line.
- Within past six months, history of active heart disease, stroke, respiratory disease, or increased intracranial pressure such as after infarction or trauma.
- Pregnant women. A urine test will be conducted on all post-menarchal females of childbearing age and potential to verify they are not pregnant.
- History of significant head trauma (loss of consciousness \>10 minutes) within the past 6 months.
- Currently taking tricyclic anti-depressants, bupropion, or neuroleptic medications.
- Intracranial metal (e.g., cortical stimulator, deep brain stimulator, intraventricular catheter) within 4 cm of optimal stimulation site. Location of cranial metal (e.g. skull screws) should be carefully documented.
- Neurodegenerative disease.
- Radiographic or electrophysiologic evidence for deep structure seizure focus (e.g., mesial temporal sclerosis or periventricular heterotopia)
- Inability to remain seated and relatively still for 30 minutes.
- Benign rolandic epilepsy.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02264652
Start Date
August 1 2014
End Date
December 1 2016
Last Update
January 26 2018
Active Locations (2)
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1
Boston Children's Hospital - Neurology
Boston, Massachusetts, United States, 02115
2
Neurology
New York, New York, United States, 10016