NCT07423923

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
48mo left

Started Apr 2025

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2025Mar 2030

Study Start

First participant enrolled

April 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2030

Last Updated

April 30, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

February 6, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

scopolamine, memory training, hippocampus, brain oscillation

Outcome Measures

Primary Outcomes (4)

  • behavioral: navigational accuracy

    accuracy (path error) of routes taken in virtual environment

    from enrollment to end of study (3 days)

  • intracranial EEG low-frequency oscillatory power

    approximate amplitude of signal recorded from the hippocampus of patients undergoing seizure monitoring

    from enrollment to the end of study (3 days)

  • memory accuracy (as part of memory training component involving healthy controls)

    how many words remembered

    from enrollment to the end of study (3 weeks)

  • Route replay time

    time (in seconds) it takes to remember a route that will or has been taken

    from enrollment to the end of study (3 days)

Study Arms (1)

Patients undergoing surgical monitoring to plan resections for epilepsy

EXPERIMENTAL

Patients will have electrodes implanted in their hippocampus for surgical monitoring allowing for direct recordings. Patients will receive scopolamine on one day and placebo on another.

Drug: Scopolamine

Interventions

effects of scopolamine on brain oscillations, navigation, and memory

Patients undergoing surgical monitoring to plan resections for epilepsy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify 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)
  • \. 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.
  • 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
  • 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.
  • History of renal insufficiency.
  • Patients with liver failure.
  • Patients with autoimmune neuropathy.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona Psychology Department and Evelyn McKnight Brain Institute

Tucson, Arizona, 85721, United States

Location

University of Texas Southwestern Medical Center / O'Donnell Brain Institute

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Seger SE, Kriegel JLS, Lega BC, Ekstrom AD. Memory-related processing is the primary driver of human hippocampal theta oscillations. Neuron. 2023 Oct 4;111(19):3119-3130.e4. doi: 10.1016/j.neuron.2023.06.015. Epub 2023 Jul 18.

    PMID: 37467749BACKGROUND
  • Zheng L, Boogaart Z, McAvan A, Garren J, Doner SG, Wilkes BJ, Groves W, Yuksel E, Cherep L, Ekstrom A, Weisberg SM. Newly trained navigation and verbal memory skills in humans elicit changes in task-related networks but not brain structure. Elife. 2025 Oct 28;14:RP106873. doi: 10.7554/eLife.106873.

    PMID: 41150161BACKGROUND

MeSH Terms

Interventions

Scopolamine

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Arne Ekstrom, Ph.D.

    University of Arizona McKnight Brain Institute

    PRINCIPAL INVESTIGATOR
  • Brad Lega, M.D.

    University of Texas, Southwestern Medican Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 20, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

March 29, 2030

Study Completion (Estimated)

March 29, 2030

Last Updated

April 30, 2026

Record last verified: 2026-02

Locations