RecruitingNCT05927974

Investigating Dynamic Interactions in Distributed Cognitive Control Networks


Sponsor

University of Alabama at Birmingham

Enrollment

30 participants

Start Date

Mar 27, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria4

  • 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

Interventions

DIAGNOSTIC_TESTPassive testing

Passive 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.

DIAGNOSTIC_TESTActive testing

Active 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.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT05927974


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