Pharmacological Modulation of Brain Oscillations in Memory Processing

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05594017
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Cognitive Impairment, Mild
  • Epilepsy
  • Memory Disorders
  • Memory Loss
  • Seizures

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Scopolamine (0.4mg) — DRUG
    Patient receives a dose of scopolamine (0.4mg) via IV fifteen minutes prior to spatial or episodic memory task/completion.
  • Placebo — DRUG
    Patient receives a dose of saline via IV fifteen minutes prior to spatial or episodic memory task/completion.

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Scopolamine (0.4mg)
    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. 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.
  • Placebo Comparator: Placebo
    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. 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.

Primary Outcome Measure

Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 1 post-intervention (approx. within 1-3 hrs) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Bradley C Lega, MD
[email protected]
(713) 834-2497

Find similar trials in Dallas, TX

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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