This is a research study to determine how COBENFY KarXT (FDA approved), a drug which has been approved for treatment of certain disorders, affects brain activity and cognitive tasks which may be regulated by the cholinergic system.
This study aims to answer: 1) how cholinergic circuitries act during task performance in humans, and 2) develop a better understanding of how cognitive control interacts with learning, memory and decision making in the setting of cholinergic manipulation.
Participants will complete a single treatment arm, regardless of which surgical procedure they are to receive. An anesthesiologist or other clinical staff will administer either the drug or the saline at a critical point which addresses the research questions, prior to patient surgery. This will be either with the drug, or the placebo pill. Half of the participants will be randomized to receive the drug, and the other half of these the placebo. Participants will be unaware whether the actual drug has been received.
Essential tremor patients who participate will complete a cognitive task during an awake surgery. Epilepsy patients who participate will have a resting state recording during the procedure from the deep cortical layers of the brain. A probe will be used during the surgery to measure the effects of this drug and other procedures of the study on the cholinergic system. This probe is the clinical probe known as the AlphaOmega, which is FDA approved for standard of care procedures.
Researchers will compare the brain activity between treatment arms to determine what brain activity changes based on the cholinergic manipulation.
Diagnosis of Essential Tremor
Recommended to undergo deep brain stimulation implantation surgery for surgical management of medication-resistant tremor based on clinical indications
Patients with recent use (within one week) of anticoagulant or antiplatelet agent
Contraindication to use of cholinergic modulation
Diagnosis of intractable epilepsy
Undergoing neuromodulation procedure that utilizes insertion of electrodes into subcortical structures, including the thalamus or hippocampus
Factorial
Cobenfy KarXT pill (50/20 mg)
DrugSubjects will receive Cobenfy KarXT pill (50/20 mg) 2 hours prior to surgery.
Placebo
DrugSubjects will receive placebo pill (equivalent of 50/20mg) 2 hours prior to surgery.
Cognitive control task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)
Cognitive control task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs) is measured by comparing the cognitive control task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.
Cognitive control task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs)
Cognitive control task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs) is measured by comparing the cognitive control task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.
Memory task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)
Memory task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs) is measured by comparing the associative memory or recognition task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.
Memory task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs)
Memory task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs) is measured by comparing the associative memory or recognition task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.
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University of Texas Southwestern Medical Center
Lead sponsor
Peter O'Donnell Jr. Brain Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
