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COBENFY KarXT for Brain Activity During Surgery

This study is looking at how the drug COBENFY KarXT affects brain activity and thinking skills during surgery. COBENFY KarXT is already approved for other conditions and is thought to work on a system in the brain called the cholinergic system, which is involved in memory and learning. Researchers want to understand how this system works during tasks and how it influences memory and decision-making when COBENFY KarXT is given. You would receive either COBENFY KarXT or a placebo (an inactive pill) about two hours before your scheduled surgery. The study aims to enroll 30 participants who are undergoing surgery for conditions like Essential Tremor or Epilepsy.

Study design
This interventional study plans to enroll 30 participants. It is a randomized, placebo-controlled study where you would receive either the COBENFY KarXT pill or a placebo pill.
What's involved
You would be contacted by phone before your surgery to discuss the study. If you agree to participate, you would receive either the study drug or placebo about two hours before your surgery.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured at baseline and again about 2-5 hours after receiving the study drug or placebo.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07721272

Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation

Not Yet Recruiting
EARLY_PHASE1Ages 18–70InterventionalBasic science
University of Texas Southwestern Medical Center
~30 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Cobenfy KarXT pill (50/20 mg)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognitive control task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)
Measured over Baseline, at cholinergic modulation post-intervention (approx. within 2-5 hrs)
+9 more outcomes measured

Conditions

Epilepsy
Essential Tremor
Seizures
Memory Consolidation
Memory Disorders
Memory Replay
Memory Encoding
Cognitive Control
Motor Abilities

Explore related trials

Essential TremorSeizure Disorder

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Bradley C Lega, MC · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Bradley C Lega, MD
[email protected]
214-648-7816
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of Essential Tremor
Recommended to undergo deep brain stimulation implantation surgery for surgical management of medication-resistant tremor based on clinical indications
Diagnosis of intractable epilepsy
Undergoing neuromodulation procedure that utilizes insertion of electrodes into subcortical structures, including the thalamus or hippocampus
Undergoing neuromodulation procedure that utilizes frame-based insertion of electrodes into the thalamus (ANT or CM)
Is patient between 18-70?
In general good health, aside from history of epilepsy or essential tremor, as ascertained by medical history, physical exam, clinical labs, and ECG?
Candidate for surgery as determined independently by the patient's treating physician/clinical team as part of the patient's routine medical care?
Able to read, understand, and provide written, dated informed consent, and participate in cognitive tasks?

Exclusion

Patients with recent use (within one week) of anticoagulant or antiplatelet agent
Contraindication to use of cholinergic modulation
Patients with recent use (within one week) of anticoagulant or antiplatelet agent
Contraindication to use of cholinergic modulation
Female that is pregnant, breastfeeding, or has a positive pregnancy test?
Under 18, over 70, or currently a prisoner on medical release?
Hepatic impairment (moderate or severe)?
Renal impairment (moderate or severe)?
Untreated narrow angle glaucoma?
Bladder obstruction, prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention?
History of hypersensitivity to COBENFY or trospium chloride?
Biliary disease, including symptomatic gallstones, gallbladder disorders, pancreatitis?
Fluoxetine, paroxetine, bupropion, terbinafine?
Buspirone or eletriptan?
Digoxin, colchicine, apixaban?
Diphenhydramine, beztropine, oxybutynin?
Benztropine, trihexyphenidyl, tolterodine, solifenacin, darifenacin, fesoterodine, hyoscyamine, dicyclomine, scopolamine?

What this trial measures

  • Cognitive control task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)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)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)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)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.

  • Working-memory task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)Baseline, at cholinergic modulation post-intervention (approx. within 2-5 hrs)

    Working-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 spatial or verbal working memory task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.

  • Working-memory task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs)Baseline, at placebo post-intervention (approx. within 2-5 hrs)

    Working-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 spatial or verbal working memory task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.

  • Navigation and memory task-related changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)Baseline, at cholinergic modulation post-intervention (approx. within 2-5 hrs)

    Navigation and 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 spatial navigation and memory task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.

  • Navigation and memory task-related changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs)Baseline, at placebo post-intervention (approx. within 2-5 hrs)

    Navigation and 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 spatial navigation and memory task with the electrical readings collected across all bandwidths, but focusing on primarily slow theta and spike changes.

  • Changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs)Baseline, at cholinergic modulation post-intervention (approx. within 2-5 hrs)

    Changes in brain electrical activity in participants from baseline at cholinergic modulation post-intervention (approx. within 2-5 hrs) by comparing the passive recording of the patient under anesthesia during cholinergic manipulation with the baseline activity electrical readings collected across all bandwidths, focusing on primarily slow theta and spike changes.

  • Changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs)Baseline, at placebo post-intervention (approx. within 2-5 hrs)

    Changes in brain electrical activity in participants from baseline at placebo post-intervention (approx. within 2-5 hrs) by comparing the passive recording of the patient under anesthesia during placebo with the baseline activity electrical readings collected across all bandwidths, focusing on primarily slow theta and spike changes.