Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05594017

Conditions

Epilepsy

Seizures

Cognitive Impairment, Mild

Memory Disorders

Memory Loss

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Scopolamine (0.4mg)

Placebo

Study Details

Brief 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

Epilepsy

Seizures

Cognitive Impairment, Mild

Memory Disorders

Memory Loss

Study ID

NCT05594017

Start date

Aug 1, 2019

Status verified date

Sep, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Patient inclusion criteria:

1. Age 18 - 55 years, all races/ethnicities, and both genders are eligible.
2. Candidates for pre-operative evaluation using stereo intracranial electrodes and admission to the Epilepsy Monitoring Unit (EMU) as determined independently by the patient's treating physician as part of the patient's routine medical care.
3. Able to read, understand, and provide written, dated informed consent prior to screening.
4. In good general health, aside from a history of epilepsy, as ascertained by medical history, physical examination (PE), clinical laboratory evaluations, and ECG.
5. Body mass index between 18-35 kg/m2.

Patient exclusion criteria:

1. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to the study physician.
2. Female that is pregnant, breastfeeding, or has a positive pregnancy test at screening or baseline. Note that pregnant patients are excluded from undergoing iEEG generally and all patients undergo a positive screening urine test for drugs of abuse at screening: cannabinoids, cocaine, amphetamines, barbiturates, opiates not otherwise explained by their prescribed medications.
3. History of renal insufficiency.
4. Unstable cardiac syndrome or active cardiac symptoms.
5. Patients with liver failure.
6. Patients with BPH.
7. Patients with autoimmune neuropathy.
8. Patients with uncontrolled hyperthyroidism.
9. Patients with a history of dementia.
10. Patient with a history of delirium after using transdermal scopolamine.
11. History of narrow-angle glaucoma.
12. History of pyloric obstruction or paralytic ileus.
13. History of myasthenia gravis, obstructive uropathy, porphyria, or myasthenia gravis.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Scopolamine (0.4mg)

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

Placebo

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

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) ]
  • Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 2 post-intervention (approx. within 1-3 hrs) ]
  • 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) ]
  • Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 2 post-intervention (approx. within 1-3 hrs) ]
  • 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) ]
  • Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 2 post-intervention (approx. within 1-3 hrs) ]
  • 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) ]
  • Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 2 post-intervention (approx. within 1-3 hrs) ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Keywords

  • oscillatory changes
  • cholinergic antagonist
  • muscarinic antagonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-10-03.