Epilepsy, Complex Partial Clinical Trial
Official title:
Neural Correlates of Cognition and Mood
The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. In the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. As such, this study has the following specific aims: Aim 1: Establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ECoG/SEEG recording platform Aim 2: Quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase II epilepsy monitoring Aim 3: Assess the relationship between validated surveys/tasks and electrophysiology
Study interventions are limited entirely to validated surveys completed on a computer or tablet PC, as outlined above. Patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are FDA-approved for the same indications. Patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer. The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. As this is a feasibility study, we are interested in the practical aspects of data acquisition. Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00143143 -
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT01002820 -
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
|
Phase 2 | |
| Completed |
NCT00001489 -
Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
|
N/A | |
| Completed |
NCT00425282 -
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00433667 -
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT03156439 -
Bioavailability, Safety, and Tolerability of BIS-001 ER
|
Phase 1 | |
| Completed |
NCT00740623 -
A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00744731 -
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
|
Phase 3 | |
| Completed |
NCT00319501 -
Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.
|
Phase 3 | |
| Completed |
NCT00991757 -
An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00056576 -
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
|
Phase 3 | |
| Terminated |
NCT01128712 -
Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
|
Phase 4 |