AnxietyCAMERANCT06551090
Prediction of Anxiety and Memory State
A study testing CAMERA (Context-Aware Multimodal Ecological Research and Assessment) in people with Anxiety and Memory, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- CAMERA (Context-Aware Multimodal Ecological Research and Assessment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Brett E Youngerman, MD, 646-317-2887, bey2103@cumc.columbia.edu
Brett E Youngerman, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- CAMERA (Context-Aware Multimodal Ecological Research and Assessment)
- Medical subject headings
- Anxiety Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CAMERA (Context-Aware Multimodal Ecological Research and Assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-30 days
Secondary outcomes (1)
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.
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start23 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers University, University of Minnesota
- Responsible party
- Principal investigator, Brett Youngerman, Columbia University
- Investigators
- Joshua Jacobs, PhD, Study director, University of ChicagoBrett E Youngerman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551090
- Sponsor's protocol ID
- AAAU7374
- Other IDs
- 1R61MH135405-01
- Acronym
- CAMERA
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing the Context-Aware Multimodal Ecological Research and Assessment (CAMERA) Platform for Continuous Measurement and Prediction of Anxiety and Memory State
- ClinicalTrials.gov ID
- NCT06551090
- Acronym / sponsor ID
- CAMERA / AAAU7374
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers University, University of Minnesota
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAMERA | Other | Other: CAMERA (Context-Aware Multimodal Ecological Research and Assessment)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | CAMERA |
Primary outcome
Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores
Time frame: 1-30 days
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.
Percent of subjects demonstrating improvement in the EMANet prediction over time.
Time frame: 1-30 days
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 secondary outcome
Mean absolute error between predicted and actual absolute error on a daily basis
Time frame: 1-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Jacobs, PhD study director
University of Chicago
Brett E Youngerman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMERA (Context-Aware Multimodal Ecological Research and Assessment) in people with Anxiety and Memory, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett E Youngerman, MD (516-946-2145, bey2103@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores (time frame: 1-30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.