Effects of scopolamine on brain activity related to memory in epilepsy patients

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

This study is testing if the drug scopolamine can change how well people with epilepsy remember things by looking at their brain activity while they do memory tasks.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05594017 on ClinicalTrials.gov

What this trial studies

This study investigates how scopolamine, an anticholinergic drug, affects brain oscillations involved in memory processing in patients with epilepsy. Participants undergoing intracranial monitoring for seizure management will be randomly assigned to receive either scopolamine or a saline placebo. The study aims to determine if scopolamine influences memory encoding and retrieval, as well as to analyze the resulting changes in brain activity. Cognitive tasks will be administered during the monitoring period to assess these effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 with pharmacologically resistant epilepsy who are undergoing invasive EEG monitoring.

Not a fit: Patients with significant health abnormalities or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of memory processing and lead to improved treatments for cognitive impairments in epilepsy patients.

How similar studies have performed: Previous studies have shown that cholinergic modulation can affect memory processes, suggesting potential for success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Bradley C Lega, MD — University of Texas Southwestern Medical Center
• Study coordinator: Bradley Lega, MD

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