Pharmacological Modulation of Brain Oscillations in Memory Processing

NCT05594017 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Scopolamine (0.4mg)

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

DRUG

Placebo

Patient receives a dose of saline via IV fifteen minutes prior to spatial or episodic memory task/completion.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2026-11-30
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594017 on ClinicalTrials.gov