Functional MRI for Coma

(PREDICT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Imminent death, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how brain scans, such as functional MRI, can reveal the level of consciousness in people with brain injuries. It examines whether these scans can predict if and how consciousness might improve over time. Participants include those who have had a brain injury and are currently in a coma or similar state. The trial involves undergoing functional MRI, sometimes with sounds or other stimuli, to assess brain responses. This study targets individuals who recently experienced a brain injury and cannot follow commands due to their condition. As an unphased trial, this research offers participants the opportunity to contribute to groundbreaking insights into brain recovery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that functional MRI is safe for patients with disorders of consciousness?

Research has shown that functional MRI (fMRI) is generally safe and well-tolerated, even for individuals with brain injuries. Studies have found that fMRI can safely detect brain activity and signs of consciousness in those who appear unresponsive. For instance, one study discovered that 25% of unresponsive patients could perform mental tasks during an fMRI scan.

There are no major reports of harmful effects from using fMRI in these patients. During a scan, patients might feel some discomfort or anxiety due to the machine's loud noises or the need to stay still, but these issues are usually manageable.

Overall, fMRI is considered a safe tool for medical research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using functional MRI for coma patients because it offers a novel way to assess brain activity without relying on a patient’s ability to communicate or move. Unlike traditional coma assessment methods, which often depend on physical responses, functional MRI can reveal brain activity patterns in response to stimuli like sounds or pain. This technique could potentially identify signs of consciousness or brain function that other methods might miss, leading to more informed decisions about patient care and prognosis.

What evidence suggests that functional MRI is effective for assessing consciousness in coma patients?

Research has shown that functional MRI (fMRI), which participants in this trial will undergo, can help predict recovery in patients with consciousness disorders after a brain injury. Studies have found that 25% of patients who seem unresponsive can actually perform mental tasks, detectable by fMRI. Resting-state fMRI, a type of brain scan done while the person is at rest, has been used to predict recovery potential in these patients. It helps identify those with a good or poor chance of recovery. These findings suggest that fMRI could play a crucial role in understanding and predicting recovery in patients with brain injuries. ^{1 4 6 7 8}

Who Is on the Research Team?

David J Fischer, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for patients with disorders of consciousness due to acute brain injury, such as coma or vegetative state. It aims to understand how well functional MRI can show their current level of consciousness and predict recovery.

Inclusion Criteria

I am 18 years old or older.

I have had a recent brain injury.

Enrolled within 28 days of brain injury

Exclusion Criteria

Imminent death (as indicated, for example, by planned transition to palliative measures, brain death testing, or severe medical instability)

MRI contraindications would exclude patients from imaging component of study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a detailed behavioral consciousness assessment and functional MRI with auditory stimulation

1 month

1 visit (in-person)

Hospitalization

Functional MRI scans and behavioral assessments are conducted to detect covert consciousness and functional network connectivity

1 month

Multiple visits (in-person)

Follow-up

Participants are monitored for overt consciousness recovery at hospital discharge, and 3 and 6 months after

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Functional MRI

Trial Overview The study uses functional MRI (fMRI) to investigate the relationship between neuroimaging metrics like covert consciousness and network connectivity, and a patient's present and future levels of consciousness.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Patients and healthy controls will undergo functional MRI, which may include auditory and noxious stimulation.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3811121/

Functional MRI and Outcome in Traumatic Coma - PMC In this review, we discuss the basic principles of fMRI, rs-fMRI and ASL and their potential applications as prognostic tools for patients with traumatic coma.

2. nature.com nature.com/articles/s41598-020-68683-y

Outcome prediction with resting-state functional ... Our primary aim was to assess the potential contribution of resting-state-functional magnetic resonance imaging (RS-fMRI) in predicting neurological outcome.

3. auntminnie.com auntminnie.com/clinical-news/mri/article/15681788/nejm-fmri-indicates-that-some-unresponsive-patients-perform-cognitive-tasks

NEJM: fMRI indicates that some unresponsive patients ... Functional MRI (fMRI) indicates that 25% of unresponsive brain injury patients can still perform cognitive tasks, according to a study published August 14.

4. ajnr.org ajnr.org/content/early/2020/05/21/ajnr.A6572

Resting-State Brain Activity for Early Prediction Outcome in ... Resting-state fMRI might bridge the gap left in early prognostication of postanoxic patients in a coma by identifying those with both good and poor outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213158225000336

Predictive value of resting-state fMRI graph measures in ... Current multimodal prediction models can determine the prognosis of about half of comatose cardiac arrest patients. We investigated whether whole-brain ...

6. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05045-4

Alteration in early resting‑state functional MRI activity in ... This study aimed to explore the characteristics of abnormal regional resting-state functional magnetic resonance imaging (rs-fMRI) activity in comatose patients

7. academic.oup.com academic.oup.com/brain/article/139/1/292/2468793

Ethical considerations in functional magnetic resonance ... To date, four published studies have used functional MRI in acutely comatose patients (defined as a Glasgow Coma Scale score ≤8 at enrolment).

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2017.00688/full

Functional MRI Motor Imagery Tasks to Detect Command ... Here, we compare the rate of covert consciousness detection by hand squeezing and tennis playing motor imagery paradigms in 10 patients with ...