What this study is
Neural diseases such as stroke can have distinct effects on the ability to navigate and orient compared to remembering daily events like when one last took medicine. This proposal seeks test rival hypotheses regarding the neural mechanisms underlying commonalities and differences in navigation and event-related memory, particularly as they relate to pre-existing knowledge. Such mechanistic insight could help inspire therapies that could be used to bolster intact brain function in a compensatory manner following strokes or other neural insults.
What's being tested
- Scopolamine
Intervention · DRUG
effects of scopolamine on brain oscillations, navigation, and memory
Study details
- Sponsor
- University of Arizona
- Conditions
- Scopolamine or Placebo · Schema to Organize Memory or no Schema
- Enrolling
- 15 people
- Starts
- 2025-04-01
- Est. completion
- 2030-03-29
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 40 YearsSex ALLHealthy volunteers AcceptedPatient for iEEG
You may qualify if
- Inclusion Criteria (for healthy young adults in fMRI studies); Able to provide verbal and written informed consent; Fluent English speaker; At least 8th grade education; Age between 18-40 years.; Normal or corrected-to-normal eyesight
- Adult patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes or depth electrodes or stereo-electroencephalography to localize the site of seizure onset.
You can't join if
- Magnetic resonance imaging contraindications (e.g., metallic objects in body, claustrophobia)
- Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
- Neurologic conditions affecting the brain (e.g., stroke, epilepsy, traumatic brain injury with loss of consciousness)
- Psychiatric conditions (e.g., major depression, schizophrenia)
- Patients with gross structural abnormalities (hematoma, tumors, large vascular malformations, diffuse malformations of cortical development) that may impact critical perceptual or memory areas needed to perform tasks.
- Patients who are unable to participate in memory testing due to impaired cognition or mental retardation. All patients routinely undergo a detailed neuropsychological evaluation, and the neuropsychological report will be used to make this assessment.
- Patients/volunteers with cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices cannot be included in this study, because of possible effects of high power magnetic fields on them.
- Patients with claustrophobia who cannot undergo an MRI scan without sedation.
- Pregnant women
- History of renal insufficiency.
- Patients with liver failure.
- 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 (due to increased eye pressure).
- History of pyloric obstruction or paralytic ileus.
- History of myasthenia gravis, obstructive uropathy, porphyria, or myasthenia gravis.
Patient for scopolamine
You may qualify if
- Inclusion Criteria (for healthy young adults in fMRI studies); Able to provide verbal and written informed consent; Fluent English speaker; At least 8th grade education; Age between 18-40 years.; Normal or corrected-to-normal eyesight
- 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.
You can't join if
- Magnetic resonance imaging contraindications (e.g., metallic objects in body, claustrophobia)
- Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
- Neurologic conditions affecting the brain (e.g., stroke, epilepsy, traumatic brain injury with loss of consciousness)
- Psychiatric conditions (e.g., major depression, schizophrenia)
- Patients with gross structural abnormalities (hematoma, tumors, large vascular malformations, diffuse malformations of cortical development) that may impact critical perceptual or memory areas needed to perform tasks.
- Patients who are unable to participate in memory testing due to impaired cognition or mental retardation. All patients routinely undergo a detailed neuropsychological evaluation, and the neuropsychological report will be used to make this assessment.
- Patients/volunteers with cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices cannot be included in this study, because of possible effects of high power magnetic fields on them.
- Patients with claustrophobia who cannot undergo an MRI scan without sedation.
- Pregnant women
- History of renal insufficiency.
- Patients with liver failure.
- 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 (due to increased eye pressure).
- History of pyloric obstruction or paralytic ileus.
- History of myasthenia gravis, obstructive uropathy, porphyria, or myasthenia gravis.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Arizona Psychology Department and Evelyn McKnight Brain Institute
Tucson, Arizona, United States
University of Texas Southwestern Medical Center / O'Donnell Brain Institute
Dallas, Texas, United States
Study team
Sponsor
University of Arizona
Study ID 2R01NS076856-11
Principal investigator
Arne Ekstrom, Ph.D.
University of Arizona McKnight Brain Institute
Study director
Brad Lega, M.D.
University of Texas, Southwestern Medican Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.