RECRUITING

Pharmacological Modulation of Brain Oscillations in Memory Processing

Conditions

Epilepsy Seizures Cognitive Impairment, Mild Memory Disorders Memory Loss oscillatory changes cholinergic antagonist muscarinic antagonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Behavioral and Pharmacological Manipulation of Time Cell Activity in the Human Mesial Temporal Lobe

Quick Facts

Study Start:2019-08-01

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05594017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Bradley Lega, MD

CONTACT

214-648-7816

Bradley.Lega@UTSouthwestern.edu

Principal Investigator

Bradley C Lega, MD

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Bradley C Lega, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-01

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2019-08-01

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

oscillatory changes
cholinergic antagonist
muscarinic antagonist

Additional Relevant MeSH Terms

Epilepsy
Seizures
Cognitive Impairment, Mild
Memory Disorders
Memory Loss