Epilepsy Clinical Trial
Official title:
Efficacy of Transcranial Direct Current Stimulation for Treating Working Memory Dysfunction and Depression For Patients With Temporal Lobe Epilepsy
Memory difficulty ranks among the most common complaints for patients with temporal lobe epilepsy. While these cognitive problems may affect quality of life more than seizure frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a method of safe, noninvasive, and painless brain stimulation delivering low intensity direct current through scalp electrodes to modulate brain activity. Several recently published studies demonstrate the enhancement of working memory and mood with stimulation of the frontal region of the brain. Furthermore, tDCS has never been reported to have induced a seizure. The aim of our study is to determine whether real tDCS can improve memory function and mood. The investigators are enrolling patients with well-controlled temporal lobe epilepsy who have not undergone brain surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. age between 18-70 years 2. diagnosis of temporal lobe epilepsy, with seizure focus defined by seizure semiology, EEG, MRI Brain, PET and/or ictal and interictal SPECT. 3. Must have a stable seizure frequency in the two (2) months prior to enrollment, as verified by the patient's seizure log and/or clinic notes and without recent antiepileptic medication changes. 4. Must score above 22/30 on the Montreal Cognitive Assessment (MoCA). 5. Must be able to provide informed consent. Exclusion Criteria: 1. Patient has a progressive or unstable neurological or systemic disease 2. Patient has an ictal focus over the F3 or F4 (DLPFC) field 3. Patient has a history of severe depression, as determined by a screen inventory test such as the Beck Depression Inventory or a psychiatrist 4. Patient has a history of severe traumatic brain injury or prior brain surgery with skull defect 5. Contraindictations to tDCS, including metal in the head or implanted brain medical devices 6. Pregnancy 7. Any implanted electrical medical device, including pacers and implanted cardiac defibrillators 8. History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year 9. History of dementia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Neurology | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | American Academy of Neurology, American Epilepsy Society, Epilepsy Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in EEG Power | Visits 1, 5, 6 & 7 over 5 weeks | No | |
Secondary | Cognitive Tests | RAVLT Digits forward and backward testing Letter and Number Sequencing Visuospatial working memory and executive function tests | Visits 1, 5, 6 & 7 over 5 weeks | No |
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