High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy
Completed · Phase 1
Conditions studied: Epilepsy
In brief
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-ring configuration with the central cathodal electrode placed over the identified target and surrounding return electrodes forming approximately a 5-cm radius ring. Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could potentially suppress seizures in refractory partial-onset epilepsy.
Key facts
- Study ID
- NCT02264652
- Run by
- NYU Langone Health
- People needed
- 1
- Starts
- 2014-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-01-26
Who can join
Age: 9 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Boston Children's Hospital - Neurology — Boston, Massachusetts, United States
- Neurology — New York, New York, United States
Full record on ClinicalTrials.gov
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