Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures, Cognitive Impairment, Mild
About this trial
This is an interventional basic science trial for Epilepsy focused on measuring oscillatory changes, cholinergic antagonist, muscarinic antagonist
Eligibility Criteria
Patient inclusion criteria:
- Age 18 - 55 years, all races/ethnicities, and both genders are eligible.
- 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.
- Able to read, understand, and provide written, dated informed consent prior to screening.
- In good general health, aside from a history of epilepsy, as ascertained by medical history, physical examination (PE), clinical laboratory evaluations, and ECG.
- Body mass index between 18-35 kg/m2.
Patient exclusion criteria:
- 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.
- 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.
- History of renal insufficiency.
- Unstable cardiac syndrome or active cardiac symptoms.
- Patients with liver failure.
- Patients with BPH.
- Patients with autoimmune neuropathy.
- Patients with uncontrolled hyperthyroidism.
- Patients with a history of dementia.
- Patient with a 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, porphyria, or myasthenia gravis.
Sites / Locations
- University of Texas Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Scopolamine (5ug/kg)
Placebo
Subjects will receive a dose of scopolamine (5ug/kg) 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.
Subjects will receive saline (5ug/kg) 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.