[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648608":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":34,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":100,"overallStatus":108,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Essential Tremor w\u002FPlacebo","PLACEBO_COMPARATOR","Subjects will receive placebo pill (equivalent of 50\u002F20mg) 2 hours prior to surgery. During awake surgery, the participant will complete either an episodic memory, a spatial memory, a working memory, or a cognitive control task session.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Essential Tremor w\u002FCobenfy KarXT (xanomeline and trospium chloride)","EXPERIMENTAL","Subjects will receive Cobenfy KarXT pill (50\u002F20 mg) 2 hours prior to surgery. During awake surgery, the participant will complete either an episodic memory, a spatial memory, a working memory, or a cognitive control task session.",[19],"Drug: Cobenfy KarXT pill (50\u002F20 mg)",{"label":21,"type":10,"description":22,"interventionNames":23},"Epilepsy w\u002FPlacebo","Subjects will receive placebo pill (equivalent of 50\u002F20mg) 2 hours prior to surgery. A passive recording with the patient under anesthesia during placebo state will be conducted in order to observe layer-specific baseline firing rate that can be linked with extraoperative ex vivo and in vivo recordings in other contexts.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Epilepsy w\u002FCobenfy KarXT (xanomeline and trospium chloride)","Subjects will receive Cobenfy KarXT pill (50\u002F20 mg) 2 hours prior to surgery. A passive recording with the patient under anesthesia during cholinergic manipulation will be conducted in order to observe layer-specific changes in firing rate that can be linked with extraoperative ex vivo and in vivo recordings in other contexts.",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Cobenfy KarXT pill (50\u002F20 mg)","Subjects will receive Cobenfy KarXT pill (50\u002F20 mg) 2 hours prior to surgery.",[25,15],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Subjects will receive placebo pill (equivalent of 50\u002F20mg) 2 hours prior to surgery.",[21,9],[40],{"name":41,"affiliation":5,"role":42},"Bradley C Lega, MC","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Bradley C Lega, MD","CONTACT","214-648-7816","Bradley.Lega@UTSouthwestern.edu",[50],{"facility":5,"status":34,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Dallas","Texas","75390","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-96.80667,32.78306,{"lat":60,"lon":59},[63],{"name":45,"role":46,"phone":64,"phoneExt":34,"email":65},"(713) 834-2497","bradley.lega@utsouthwestern.edu",{"type":42,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Bradley Lega","Professor",[70],{"name":71,"class":72},"Peter O'Donnell Jr. Brain Institute","UNKNOWN","100648608","early-phase-1-human-cognition-during-surgery-stimulation-based-and-cholinergic-modulation-100648608",false,"NCT07721272","Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation","Studying Human Cognition During Deep Brain Stimulation Surgery Using High-Density Neural Probes and Pharmacological Interventions","Study Population\n\nInclusion Criteria for Essential Tremor Patients:\n\n* Diagnosis of Essential Tremor\n* Recommended to undergo deep brain stimulation implantation surgery for surgical management of medication-resistant tremor based on clinical indications\n\nExclusion Criteria for Essential Tremor Patients:\n\n* Patients with recent use (within one week) of anticoagulant or antiplatelet agent\n* Contraindication to use of cholinergic modulation\n\nInclusion Criteria for Epilepsy Patients\n\n* Diagnosis of intractable epilepsy\n* Undergoing neuromodulation procedure that utilizes insertion of electrodes into subcortical structures, including the thalamus or hippocampus\n* Undergoing neuromodulation procedure that utilizes frame-based insertion of electrodes into the thalamus (ANT or CM)\n\nExclusion Criteria for Epilepsy Patients:\n\n* Patients with recent use (within one week) of anticoagulant or antiplatelet agent\n* Contraindication to use of cholinergic modulation\n\nContraindication for cholinergic modulation in both patient sets will be assessed by members of the treatment team (e.g. epileptologist), as well as a neuroanesthesiologist. Multiple medications and conditions are singular disqualifiers; however some medications are eliminated only in combination following neuroanesthesiologist evaluation. Patients at risk of reaction to the treatment arm based on concurrent or recent medications or other health conditions will be excluded from participation.\n\nInclusion Criteria for Study Participation\n\n* Is patient between 18-70?\n* In general good health, aside from history of epilepsy or essential tremor, as ascertained by medical history, physical exam, clinical labs, and ECG?\n* Candidate for surgery as determined independently by the patient's treating physician\u002Fclinical team as part of the patient's routine medical care?\n* Able to read, understand, and provide written, dated informed consent, and participate in cognitive tasks?\n\nExclusion Criteria for Study Participation\n\n* Female that is pregnant, breastfeeding, or has a positive pregnancy test?\n* Under 18, over 70, or currently a prisoner on medical release?\n* Hepatic impairment (moderate or severe)?\n* Renal impairment (moderate or severe)?\n* Untreated narrow angle glaucoma?\n* Bladder obstruction, prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention?\n* History of hypersensitivity to COBENFY or trospium chloride?\n* Biliary disease, including symptomatic gallstones, gallbladder disorders, pancreatitis?\n* Fluoxetine, paroxetine, bupropion, terbinafine?\n* Buspirone or eletriptan?\n* Digoxin, colchicine, apixaban?\n* Diphenhydramine, beztropine, oxybutynin?\n* Benztropine, trihexyphenidyl, tolterodine, solifenacin, darifenacin, fesoterodine, hyoscyamine, dicyclomine, scopolamine?","ALL","18 Years","70 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"EARLY_PHASE1","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.\n\nThis 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.\n\nParticipants 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.\n\nEssential 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.\n\nResearchers will compare the brain activity between treatment arms to determine what brain activity changes based on the cholinergic manipulation.",[91,92,93,94,95,96,97,98,99],"Epilepsy","Essential Tremor","Seizures","Memory Consolidation","Memory Disorders","Memory Replay","Memory Encoding","Cognitive Control","Motor Abilities",[101,102,103,104,105,106,107],"interoperative","oscillatory changes","neuronal spiking","time cell","place cell","cholinergic agonist","cholinergic modulation","NOT_YET_RECRUITING","2026-07-17",{"date":111,"type":112},"2026-07-23","ACTUAL",{"date":114,"type":85},"2026-10",{"date":116,"type":85},"2030-09",{"name":5,"class":6},1]