Investigating Dynamic Interactions in Distributed Cognitive Control Networks
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for surgery based on multi-disciplinary consensus review
Have a diagnosis of medically-refractory epilepsy
A minimum of 18 years of age
Willingness to participate in the paradigms described in the protocol
Disqualifiers
Inability to provide full and informed consent
Age younger than 18
Are not physically able to participate in study-related activities
Major medical or surgical complication
Trial population
Patients with epilepsy undergo a routine surgery to implant electrodes into the brain for intracranial monitoring (ICM) to localize areas of the brain producing seizures.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Passive testing
Diagnostic testPassive testing includes baseline recordings or behavioral tasks without stimulation. Examples include language tasks, cognitive, and motor tasks. Passive testing typically takes 30-60 minutes and does not require presence of an epileptologist as the tasks are of minimal or no risk.
Active testing
Diagnostic testActive testing includes any study activity in which stimulation occurs. The most frequent paradigm consists of delivering small amounts of electrical stimulation through the implanted grid/strip/depth electrodes. This will be either continuous stimulation or patterned stimulation such as intermittent theta-burst . Stimulation will range between 1-8 mAmp. The duration of these pulses will last between 2-5 seconds. Subjects may be asked to rest quietly or to perform behavioral tasks during stimulation. Since there is a risk of evoking seizure activity with active testing, presence of an epileptologist is required. Active testing will only occur once the PI/staff has communicated with the epileptologist regarding safety, feasibility, and timing of active testing. Active testing will typically take 60-90 minutes and is only performed once patients are back on their anti-seizure medications.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: ICM Patients2 interventions
Trial outcomes
Primary outcomes
1
Go/No-go
Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.
Time frame
Post-op through study completion, an average of 7 days.2
Simon/Stroop task
Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.
Time frame
Post-op through study completion, an average of 7 days.3
Stop-signal task
Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.
Time frame
Post-op through study completion, an average of 7 days.4
Language task
Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.
Time frame
Post-op through study completion, an average of 7 days.Sponsors and contacts
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Source ClinicalTrials.gov