Prediction of Anxiety and Memory State (CAMERA)

Developing the Context-Aware Multimodal Ecological Research and Assessment (CAMERA) Platform for Continuous Measurement and Prediction of Anxiety and Memory State

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Anxiety; Memory
• Intervention / Treatment: Other: CAMERA (Context-Aware Multimodal Ecological Research and Assessment)

Detailed Description

CAMERA will record neural, physiological, behavioral, and environmental signals, as well as measurements from ecological momentary assessments (EMAs), to develop a continuous high-resolution prediction of a person's level of anxiety and cognitive performance. CAMERA will provide a significant advance over current methods for human behavioral measurement because it leverages the complementary features of multimodal data sources and combines them with interpretable machine learning to predict human behavior. A further distinctive aspect of CAMERA is that it incorporates context-aware, adaptive EMA, where the timing of assessments depends on the subject's physiology and behavior to improve response rates and model learning. In this study, CAMERA focuses on predicting anxiety state and concurrent memory performance, but the platform is flexible for use in various domains.

Currently, it is challenging to study complex, longitudinal relationships between the brain, body, and environment in humans. Most existent tools do not allow the investigator to measure transient internal states or cognitive functions comprehensively or continuously. Instead the investigators typically rely on sparsely collected and constrained self-reports or experimental constructs, including EMA.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Velazquez; Phone Number: 646-515-1909; Email: agv2113@cumc.columbia.edu
• Study Contact Backup: Name: Brett E Youngerman, MD; Phone Number: 516-946-2145; Email: bey2103@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Brett E Youngerman, MD; Phone Number: 646-317-2887; Email: bey2103@cumc.columbia.edu
      • Principal Investigator: Brett E Youngerman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Study Population

Subjects admitted to the Epilepsy Monitoring Unit with either Stereoelectroencephalography (SEEG) and/or scalp Electroencephalography (EEG)

Description

Inclusion Criteria:

• 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.
• 7th grade reading level (minimum level considered literate for adults)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: CAMERA; 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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error between predicted and actual absolute error on a daily basis	Use a multimodal machine learning model of prediction uncertainty (UncertaintyNet) to predict the mean absolute prediction error of ecological momentary assessment (EMA) predictions in held-out data, at single-subject level on each day. Mean absolute error will measure the difference between the predicted error (based on all available data) and the actual error.	1-30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jitter of neural data (milliseconds)	Precise synchronization of neural data with jitter <30 milliseconds.	1-30 days
Latency of audiovisual data (seconds)	Precise synchronization of audiovisual data with latency <10 seconds.	1-30 days
Latency of wrist sensor data (minutes)	Precise synchronization of wrist sensor data with latency <2 minutes.	1-30 days
Latency of smartphone data (minutes)	Precise synchronization of smartphone data with latency <20 minutes.	1-30 days
Jitter of ecological momentary assessment (EMA) delivery. (milliseconds)	Successful delivery of EMA assessments with precise synchronization of ecological momentary assessment delivery with jitter <50 milliseconds.	1-30 days
Percentage improvement in normalized response rate to ecological momentary assessment (EMA) delivery.	Successful delivery of EMA assessments with ≥10% statistically significant (p<0.05) improvement in normalized response rate over time (across subjects) with implementation of context-aware EMA delivery using ResponseNet.	1-30 days
Number of subjects demonstrating feasibility of translation to the ambulatory setting.	Collection of (synchronized) non-neural physiological, smartphone and EMA (survey and task) data from 10 outpatients in the ambulatory setting consecutively for 2 weeks with <10% passive data loss.	14 days

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); University of Minnesota; Rutgers University
• Investigators: Study Director: Joshua Jacobs, PhD, University of Chicago; Principal Investigator: Brett E Youngerman, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Anxiety Disorders; Epilepsy; Investigative Techniques; Therapeutics; Behavior Control; Immobilization; Restraint, Physical
• Other Study ID Numbers: AAAU7374; 1R61MH135405-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No