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NCT05463029 · ClinicalTrials.gov registry record
Resting State fMRI in Disorders of Consciousness
A clinical trial, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- 9
- Enrollment target
NCT05463029: Clinical Trial study, sponsored by University of Pennsylvania.
NCT05463029 is a clinical trial that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05463029 was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- 9 participants
- Enrollment target
Study Summary
Disorders of consciousness (DoC) remain a major clinical challenge in which high rates of misdiagnosis and difficult prognostication stem from limitations in the ability to access the disordered physiological processes mechanisms of coma in real world clinical settings. There is a great need to develop, validate, and translate to clinical use reliable diagnostics to detect brain recovery potential not evident on neurobehavioral assessment. While resting state fMRI (rs-fMRI) has demonstrated potential to improve the diagnostic evaluation of DoC by detecting features of consciousness that are occult at bedside evaluation, this technology has yet to achieve widespread clinical utility. The investigators propose that recent advancements in rs-fMRI capabilities can be combined with streamlined analysis and interpretation approaches to overcome persistent intensive care unit to perform rs-fMRI in patients with prolonged impaired consciousness due to several causes including TBI, cardiac arrest, stroke, seizures, and severe CNS infection. The investigators will determine the optimal methods of data acquisition, analysis and interpretation for predicting recovery of consciousness in these patients. Our expectations are that this approach will produce highly reliable functional connectomic characterization of individual DoC patients, thereby allowing for more accurate outcome prediction. The investigators will additionally investigate the utility of a novel, simplified radiological approach to rs-fMRI data interpretation in comparison to computationally intensive connectomic approaches. This exploratory/developmental project is expected to provide critical data needed to design and appropriately power future R01 studies validating the efficacy of fMRI-based network integrity in the clinical evaluation of DoC.
Primary Outcome
The interclass correlation coefficient (ICC) is used to assess the reliability of functional connectivity measures.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-07-01 |
Why NCT05463029 stopped before completion
NCT05463029 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05463029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05463029 about?
NCT05463029 is a clinical study titled "Resting State fMRI in Disorders of Consciousness". Disorders of consciousness (DoC) remain a major clinical challenge in which high rates of misdiagnosis and difficult prognostication stem from limitations in the ability to access the disordered physiological processes mechanisms of coma in real world clinical settings. There is a great need to deve...
What is the current status of trial NCT05463029?
This trial is currently terminated. The enrollment target is 9 participants. The study started on 2022-08-01. Estimated completion is 2024-07-01.
Who is sponsoring clinical trial NCT05463029?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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