Pharmacological Modulation of Brain Oscillations in Memory Processing

StatusRecruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 30, 2026 → Nov 30, 2027
See other at-risk trials from University of Texas Southwestern Medical Center

Record History

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  1. Notable Primary completion pushed from Nov 30, 2026 to Nov 30, 2027
    • Study completion pushed from May 31, 2027 to May 31, 2028
    • Eligibility criteria expanded, about 18 words
    • Study description revised
  2. Notable Primary completion date: May 31, 2026 to Nov 30, 2026
    • Study completion date: Nov 30, 2026 to May 31, 2027
    v4
  3. Minor Interventions: Placebo (Drug), Scopolamine (5ug/kg) (Drug) to Placebo (Drug), Scopolamine (0.4mg) (Drug)
    • Study description revised
    v3
  4. Minor Site contact updatedv2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05594017
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)
Epilepsy, Seizures, Cognitive Impairment, Mild, Memory Disorders, Memory Loss
Related terms Cognitive Dysfunction, Epilepsy, Memory Disorders, Seizures
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov