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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Bradley Lega, MD
Bradley.Lega@UTSouthwestern.edu
214-648-7816
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 60
Treatments
Experimental: Scopolamine (0.4mg)
Subjects will receive a dose of scopolamine (0.4mg) 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.
Placebo_comparator: Placebo
Subjects will receive saline (0.4mg) 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.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov