Amygdala Memory Enhancement

NCT05065450 | Recruiting DMC FDA Device

• 1 other identifier: 202104033
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Free recall memory discriminability index (proportion recalled)

  Proportion of items (objects, associations, and scenes) accurately recalled during the delayed recall trial will be compared with and without BLAES for each participant in a within subject design. Subsets of items may be tested after durations up to a month after initial presentation.

  5 years

• Recognition memory discriminability index (proportion recalled)

  Proportion of items (objects, associations, and scenes) accurately recognized during the delayed recognition trial will be compared with and without BLAES for each participant in a within subject design. Subsets of items may be tested after durations up to a month after initial presentation.

  5 years

Secondary Outcomes (5)

• Location of single pulse evoked potential (SPEP) response to amygdala stimulation

  5 years

• Amplitude of SPEP response to amygdala stimulation

  5 years

• Latency of SPEP response to amygdala stimulation

  5 years

• Local field potential (LFP) of good memory state

  5 years

• LFP of bad memory state

  5 years

Study Arms (1)

Brain Stimulation

EXPERIMENTAL

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.

Device: Intracranial Stimulation

Interventions

Intracranial Stimulation DEVICE

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.

Also known as: Device: ACTIVE basal lateral amygdala electrical stimulation (Active-BLAES), Device: SHAM basal lateral amygdala electrical stimulation (Sham-BLAES)

Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (5)

• Inman CS, Manns JR, Bijanki KR, Bass DI, Hamann S, Drane DL, Fasano RE, Kovach CK, Gross RE, Willie JT. Direct electrical stimulation of the amygdala enhances declarative memory in humans. Proc Natl Acad Sci U S A. 2018 Jan 2;115(1):98-103. doi: 10.1073/pnas.1714058114. Epub 2017 Dec 18.

  PMID: 29255054 BACKGROUND

• Manns JR, Bass DI. The amygdala and prioritization of declarative memories. Curr Dir Psychol Sci. 2016 Aug;25(4):261-265. doi: 10.1177/0963721416654456.

  PMID: 27721578 BACKGROUND

• Bass DI, Manns JR. Memory-enhancing amygdala stimulation elicits gamma synchrony in the hippocampus. Behav Neurosci. 2015 Jun;129(3):244-56. doi: 10.1037/bne0000052.

  PMID: 26030426 BACKGROUND

• Bass DI, Nizam ZG, Partain KN, Wang A, Manns JR. Amygdala-mediated enhancement of memory for specific events depends on the hippocampus. Neurobiol Learn Mem. 2014 Jan;107:37-41. doi: 10.1016/j.nlm.2013.10.020. Epub 2013 Nov 8.

  PMID: 24211699 BACKGROUND

• Bass DI, Partain KN, Manns JR. Event-specific enhancement of memory via brief electrical stimulation to the basolateral complex of the amygdala in rats. Behav Neurosci. 2012 Feb;126(1):204-8. doi: 10.1037/a0026462. Epub 2011 Dec 5.

  PMID: 22141467 BACKGROUND

MeSH Terms

Conditions

Brain Diseases; Epilepsy; Memory Disorders; Brain Injuries, Traumatic; Cognitive Dysfunction; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Joan Atencio

CONTACT

314-362-3114; atencio@wustl.edu

Sophie Church

CONTACT

917-699-9097; sophie.church@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: October 4, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)