Recruiting

Amygdala Memory

Sponsor:

Washington University School of Medicine

Code:

NCT05065450

Conditions

Brain Diseases

Epilepsy

Memory Disorders

Traumatic Brain Injury

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intracranial Stimulation

Study Details

Brief summary:

The objective is to understand how amygdala activation affects other medial temporal lobe structures to prioritize long-term memories. The project is relevant to disorders of memory and to disorders involving affect and memory, including traumatic brain injury and post-traumatic stress disorder.

Conditions

Brain Diseases

Epilepsy

Memory Disorders

Traumatic Brain Injury

Cognitive Impairment

Study ID

NCT05065450

Start date

Nov 1, 2021

Status verified date

Jul, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be able to understand and speak English.
  • Able to provide informed consent.
  • Diagnosed with epilepsy.
  • Scheduled to undergo long-term intra-cranial video monitoring for seizure onset localization.
  • Must be implanted with intracranial depth electrodes to the left or right amygdala, hippocampus, and parahippocampal/perirhinal cortices.

Exclusion Criteria:

  • Unable to understand and speak English.
  • Unable to provide informed consent.
  • Not diagnosed with epilepsy.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brain Stimulation

Neurosurgical epilepsy patients that undergo placement of medial temporal electrode for seizure localizations will be recruited. All participants will view a series of images of emotionally-neutral objects on a computer screen. After each item presentation, they will randomly undergo either active-BLAES or sham-stimulation. Over subsequent days, free recall and recognition memory for these items, relative to new distractor items will be tested. Memory for items presented with and without stimulation will be compared. Brain activity recorded in the medial temporal lobe during item presentations will be used to predict subsequent memory. Such good and bad memory states (biomarkers) will be used to perform closed-loop stimulation when bad memory states are detected in order to enhance subsequent memory.

Interventions

Intracranial Stimulation

Electrodes localized to the BLA will be stimulated with either active-BLAES (0.5-3.5 mA, theta-modulated gamma burst) electrical stimulation for a 1-sec duration immediately following item image presentation or sham-BLAES (zero-amplitude). At later stages of the project, stimulation parameters and timing will be varied and triggered not at random, but by real-time closed-loop analysis of memory biomarkers in the medial temporal lobe.

Primary outcome measure

  • Free recall memory discriminability index (proportion recalled) [ Time Frame: 5 years ]
  • Recognition memory discriminability index (proportion recalled) [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Jon T Willie, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-07-17.