Prediction of Anxiety and Memory State

NCT06551090 | Recruiting DMC

• 2 other identifiers: AAAU73741R61MH135405-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at how signals in the brain, body, and behavior relate to anxiety and memory function. This project seeks to develop the CAMERA (Context-Aware Multimodal Ecological Research and Assessment) platform, a state-of-the-art open multimodal hardware/software system for measuring human brain-behavior relationships. The R61 portion of the project is designed to develop the CAMERA platform, which will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy, as well as to build CAMERA's passive data framework and active data framework.

Conditions

Anxiety; Memory; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores

  Use a multimodal machine learning model (EMANet ) to predict ≥1 EMA anxiety-memory state outcome (target) in held-out data at the population level. Mean absolute error will be the mean difference in absolute value of predicted EMA and actual EMA scores. A higher mean error represents a less accurate prediction. Prediction must use ≥2 different passive modalities, showing significantly better prediction accuracy than either of the modalities alone.

  1-30 days

• Percent of subjects demonstrating improvement in the EMANet prediction over time.

  Use EMANet to predict ≥1 ecological momentary assessment (EMA) anxiety-memory state outcome (target) demonstrating improvement over time as measured with a linear regression applied to the mean absolute error between predicted and actual EMA values measured over days. Prediction must use ≥2 different passive modalities, showing significantly better prediction accuracy than either of the modalities alone.

  1-30 days

Secondary Outcomes (1)

• Mean absolute error between predicted and actual absolute error on a daily basis

  1-30 days

Other Outcomes (7)

• Jitter of neural data (milliseconds)

  1-30 days

• Latency of audiovisual data (seconds)

  1-30 days

• Latency of wrist sensor data (minutes)

  1-30 days

Study Arms (1)

CAMERA

OTHER

Adult subjects with epilepsy will undergo noninvasive video Electroencephalography (EEG) and intracranial electrodes sampling the amygdala and hippocampus (unilateral or bilateral). A subset of subjects (n=10) will use the Context-Aware Multimodal Ecological Research and Assessment (CAMERA) platform for 2 weeks after discharge with a subset of modalities: physiologic wristband, smartphone phenotyping, ecological momentary assessment (EMA) surveys, and memory task. At unpredictable intervals, CAMERA will interrupt subjects with: (a) an audible alarm to elicit an acoustic startle response; (b) a self-reported anxiety state scale; and (c) a visuospatial memory task with threat interference. For example, participants will fill out a brief survey and play a video game several times each day and wear a wristband with sensors.

Other: CAMERA (Context-Aware Multimodal Ecological Research and Assessment)

Interventions

CAMERA (Context-Aware Multimodal Ecological Research and Assessment) OTHER

The CAMERA platform is a multimodal, hardware-software framework for measuring brain-behavior interactions in an unstructured environment and predict ecological states. CAMERA will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy. CAMERA consists of: Wristband sensors of autonomic physiologic signals, emphasizing heart rate metrics and electrodermal activity; Smartphone usage, emphasizing natural language processing of text input for linguistic features; Subject-tracking audiovisual array, emphasizing subject vocal activity; Intracranial neural recordings, emphasizing hippocampal theta power and high-frequency activity (\~70-200 Hz).

CAMERA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have known or suspected Temporal Lobe Epilepsy.
• Native or proficient in speaking English or Spanish.
• Stereoelectroencephalography (sEEG) cases: The implant plan must include hippocampal head, body, and tail electrodes either unilaterally or bilaterally.
• th grade reading level (minimum level considered literate for adults)

You may not qualify if:

• Hearing impaired (i.e., not corrected with a hearing aid)
• Unable to read the newspaper at arm's length with corrective lenses.
• Objective intellectual impairment (estimated IQ \< 70)
• Any history of Electroconvulsive Therapy or psychosis (except postictal psychosis for patients)
• Psychotic disorder (lifetime)
• Current Anxiety disorder, Major Depressive Disorder, or Bipolar Disorder
• Neurodegenerative diseases, presence of widespread brain lesions, language problems (other than naming difficulty)
• Medical conditions that could potentially affect cognitive performance (e.g., human immunodeficiency virus (HIV) infection, cancer with metastatic potential).
• Acute renal failure or end-stage renal disease

Sponsors & Collaborators

• Columbia University: lead
• Rutgers University: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Minnesota: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Epilepsy

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Joshua Jacobs, PhD

  University of Chicago

  STUDY DIRECTOR

• Brett E Youngerman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett E Youngerman, MD

CONTACT

516-946-2145; bey2103@cumc.columbia.edu

Angela Velazquez

CONTACT

646-515-1909; agv2113@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 13, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)