Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT05594017

Pharmacological Modulation of Brain Oscillations in Memory Processing

Led by University of Texas Southwestern Medical Center · Updated on 2025-10-03

60

Participants Needed

1

Research Sites

408 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Pharmacological Modulation of Brain Oscillations in Memory Processing

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 55 years, any race or ethnicity, any gender
  • Candidates for pre-operative evaluation using stereo intracranial electrodes and admission to the Epilepsy Monitoring Unit as determined by their treating physician
  • Able to read, understand, and provide written informed consent before screening
  • In good general health except for epilepsy, confirmed by medical history, physical exam, lab tests, and ECG
  • Body mass index between 18 and 35 kg/m2
Not Eligible

You will not qualify if you...

  • Clinically significant abnormality on screening physical exam affecting safety or study participation
  • Female who is pregnant, breastfeeding, or has a positive pregnancy test at screening or baseline
  • History of renal insufficiency
  • Unstable cardiac syndrome or active cardiac symptoms
  • Liver failure
  • Benign prostatic hyperplasia (BPH)
  • Autoimmune neuropathy
  • Uncontrolled hyperthyroidism
  • History of dementia
  • History of delirium after using transdermal scopolamine
  • History of narrow-angle glaucoma
  • History of pyloric obstruction or paralytic ileus
  • History of myasthenia gravis, obstructive uropathy, or porphyria

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

B

Bradley Lega, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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