Prediction of Anxiety and Memory State (NCT06551090) | Clinical Trial Compass
RecruitingNot Applicable
Prediction of Anxiety and Memory State
United States40 participantsStarted 2024-07-23
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean absolute error between predicted and actual ecological momentary assessment (EMA) scores
Timeframe: 1-30 days
2
Percent of subjects demonstrating improvement in the EMANet prediction over time.