TMS-EEG for Consciousness Disorders
(COMPASS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve how doctors assess consciousness in ICU patients with severe brain injuries. It uses a tool called TMS-EEG, which combines magnetic stimulation with brain wave readings, to detect signs of consciousness and predict recovery. The study focuses on patients who recently suffered a brain injury, cannot follow commands, but can safely undergo the procedure. Researchers will monitor participants in the ICU and follow them for six months to evaluate the method's effectiveness. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could enhance future brain injury assessments.
Will I have to stop taking my current medications?
The trial information does not specify if 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 TMS-EEG is safe for patients with acute disorders of consciousness?
Research has shown that Transcranial Magnetic Stimulation with Electroencephalography (TMS-EEG) is generally safe. Studies on repetitive transcranial magnetic stimulation (rTMS), a component of TMS-EEG, have not identified any major safety issues. Serious side effects are rare, and most patients tolerate the treatment well.
In some studies, patients demonstrated improved thinking skills and reduced pain. While researchers continue to explore its effects on depression, the overall safety profile remains promising. This information may provide confidence in considering TMS-EEG in a clinical setting.12345Why are researchers excited about this trial?
Researchers are excited about using TMS-EEG (transcranial magnetic stimulation-electroencephalography) to better understand and predict recovery of consciousness in ICU patients with severe traumatic brain injuries. Unlike standard treatments, which often focus on managing symptoms and physical stabilization, this technique aims to measure brain complexity and activity in real-time. TMS-EEG provides a non-invasive way to directly stimulate and monitor brain responses, potentially offering insights into recovery patterns and long-term outcomes. This could lead to more personalized treatment plans and improved prognostic capabilities for patients with acute consciousness disorders.
What evidence suggests that TMS-EEG is effective for detecting consciousness in patients with acute disorders of consciousness?
This trial will evaluate transcranial magnetic stimulation-electroencephalography (TMS-EEG) in patients with acute disorders of consciousness. Research has shown that TMS-EEG can detect signs of awareness in patients with consciousness disorders. Studies have found that TMS can improve outcomes for patients in minimally conscious states (MCS) and persistent vegetative states (PVS), which are types of these disorders. TMS uses magnetic fields to stimulate brain cells, helping to check and sometimes boost brain activity. While more research is needed to fully confirm its benefits, early findings suggest this method could aid recovery and improve patient assessments in the ICU.26789
Who Is on the Research Team?
Brian L. Edlow, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Assessment
Participants undergo repeated behavioral assessments, task-based EEG, and TMS-EEG
Follow-up
Participants are monitored for recovery and outcomes on the Disability Rating Scale (DRS)
What Are the Treatments Tested in This Trial?
Interventions
- Functional electroencephalography and brain imagery
- Repeated behavioral assessments
- TMS-EEG
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post-injury.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
Transcranial Magnetic Stimulation-Electroencephalography ...
Abstract. Mild traumatic brain injury (mTBI) may cause diffuse damage to the brain, especially to the frontal areas, that may lead to persistent symptoms.
Patient Outcomes in Disorders of Consciousness Following ...
TMS may improve outcomes in MCS and PVS. Further evaluation with randomized, clinical trials is necessary to determine its efficacy in this patient population.
Can repetitive transcranial magnetic stimulation promote ...
The purpose of this study is to investigate the efficacy of rTMS in promoting recovery of consciousness in patients with DoC and to probe its impact on activity ...
Efficacy of repetitive transcranial magnetic stimulation for ...
To evaluate the efficacy of 5 Hz repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (left DLPFC) ...
5.
journals.lww.com
journals.lww.com/headtraumarehab/fulltext/2025/05000/seizure_risk_associated_with_the_use_of.7.aspxSeizure Risk Associated With the Use of Transcranial...
Repetitive Transcranial Magnetic Stimulation (rTMS) is emerging as a promising treatment for persons with disorder of consciousness (DoC) following traumatic ...
Use of repetitive transcranial magnetic stimulation in traumatic ...
The use of rTMS is associated with improved cognitive functions and reduction in pain. No effect was observed regarding depression but future studies are still ...
7.
clinicaltrial.be
clinicaltrial.be/en/details/448013?only_active=0&only_eligible=0&only_recruiting=0&per_page=20Measuring Brain Complexity to Detect and Predict ...
TMS-EEG measurements can predict 6-month outcomes on the Disability Rating Scale (DRS) in patients in an acute vegetative state, controlling for ...
Repetitive Transcranial Magnetic Stimulation in Traumatic ...
The protocol will be statistically compared to the same CTT administered without the r-TMS in a sample of traumatic brain injury patients (age between 18 and 80 ...
Safety Considerations for the Use of Transcranial Magnetic ...
We report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) ...
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