Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT06551090

Conditions

Anxiety

Memory

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

CAMERA (Context-Aware Multimodal Ecological Research and Assessment)

Study Details

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

Study ID

NCT06551090

Start date

Jul 23, 2024

Status verified date

Jan, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brett E Youngerman, MD

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

Angela Velazquez

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Brett E Youngerman, MD

646-317-2887bey2103@cumc.columbia.edu

Principal Investigator:

Brett E Youngerman, MD

More Information

Sponsor

Columbia University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-28.