Prediction of Anxiety and Memory State

Official title

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

Overview

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.

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.

Interventions

• 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, emphas

Primary outcome measures

• Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores [Time frame: 1-30 days]
• Percent of subjects demonstrating improvement in the EMANet prediction over time. [Time frame: 1-30 days]

Secondary outcome measures (1)

• Mean absolute error between predicted and actual absolute error on a daily basis [Time frame: 1-30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT06551090 · AAAU7374 · 1R61MH135405-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗