Clinical trial NCT05594017: Pharmacological Modulation of Brain Oscillations in Memory Processing
Official title: Behavioral and Pharmacological Manipulation of Time Cell Activity in the Human Mesial Temporal Lobe
Conditions: Epilepsy
Seizures
Cognitive Impairment, Mild
Memory Disorders
Memory Loss
Summary: The goal of this study is to learn about the effects of scopolamine (an anticholinergic drug) on areas of the brain involved in memory, and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed.
The main questions it aims to answer are 1) whether scopolamine changes memory activity solely at encoding (the time when the person perceives and determines to remember an item or event) as has previously been found, or if it also can selectively impact retrieval (when the item or event which has been processed is recalled or remembered), and 2) what the nature of the brain activity changes is.
Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a saline solution, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal and/or spatial task each of the two days. An anesthesiologist will administer either the drug or the saline at a critical point which addresses both of the research questions.
Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and at what time point during memory formation.
Interventions:
description: Patient receives a dose of scopolamine (0.4mg) via IV fifteen minutes prior to spatial or episodic memory task/completion.
name: Scopolamine (0.4mg)
type: Drug
description: Patient receives a dose of saline via IV fifteen minutes prior to spatial or episodic memory task/completion.
name: Placebo
type: Drug
Study arms:
design_group_description: Subjects will receive a dose of scopolamine (0.4mg) on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session.<br/>If the patient completed the sham session already, this session will take place the day following the initial session, or at least four half-lives after the first session.
design_group_title: Scopolamine (0.4mg)
design_group_type: Experimental
design_group_description: Subjects will receive saline (0.4mg) via IV on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session.<br/>If the patient completed the scopolamine session already, this session will take place the day following the initial session, or at least four half-lives after the first session.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The University of Texas Southwestern Medical Center
Collaborators: National Institute of Neurological Disorders & Stroke
Drug name mappings:
name: 丁溴东莨菪碱
lang: CN
name: Scopolamine Butylbromide
lang: EN
name: ブチルスコポラミン臭化物
lang: JP