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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Bradley.Lega@UTSouthwestern.edu
• Phone: 214-648-7816

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.