Jak lek COBENFY wpływa na myślenie i pamięć podczas zabiegu chirurgicznego

ClinicalTrials.gov➕ 24.07.2026Status: Jeszcze nie rekrutujeFaza: Wczesna faza 1

Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation

W skrócie

Badanie sprawdza, czy lek COBENFY (już zatwierdzony przez FDA) zmienia sposób, w jaki mózg pracuje i jak funkcjonuje nasza pamięć, myślenie oraz podejmowanie decyzji. Pacjenci przygotowujący się do zabiegu neurochirurgicznego otrzymują albo lek, albo placebo (nieaktywną tabletkę) przed operacją, a naukowcy mierzą aktywność mózgu za pomocą specjalnej sondy. Badanie dotyczy pacjentów z tremorem samoistnym (drżenie rąk) i epilepsją, którzy już planują przejść operację neurochirurgiczną.

Oryginalny opis (angielski)

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.

Metadane badania

NCT ID
NCT07721272
Status
Jeszcze nie rekrutuje
Faza
Wczesna faza 1
Sponsor
University of Texas Southwestern Medical Center
Data startu
2026-10
Choroby
Epilepsy, Essential Tremor, Seizures, Memory Consolidation, Memory Disorders, Memory Replay, Memory Encoding, Cognitive Control, Motor Abilities
Kraje
United States