Focused Ultrasound for Disorders of Consciousness
(ReBOUND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether low-intensity focused ultrasound (LIFUP) can aid recovery from severe brain injuries that result in disorders of consciousness. Researchers will assess patient responses by examining behavior and brain activity, using tools like EEG to measure brain waves. They will also gather family members' opinions on this technology. Suitable participants have experienced a brain injury leading to a consciousness disorder and must have a representative to provide consent. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could enhance recovery outcomes for future patients.
Do I need to stop my current medications to join 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 low-intensity focused ultrasound is safe for patients with disorders of consciousness?
Research has shown that low-intensity focused ultrasound (LIFUP) is generally easy for people to tolerate. Studies have found this treatment safe, which is promising as more clinical trials explore its effects. A review of LIFUP's use in humans found it safe for altering nerve activity. Although results on its effectiveness for treating consciousness disorders have varied, the treatment itself has not raised major safety concerns. Participants in past studies reported no significant side effects, making LIFUP a promising area for further research.12345
Why are researchers excited about this trial?
Unlike the standard treatments for disorders of consciousness, which often involve medications or invasive procedures, low-intensity focused ultrasound (LIFUP) offers a non-invasive approach. Researchers are excited about LIFUP because it delivers precise ultrasound waves to specific areas of the brain, potentially awakening neural pathways without the need for surgery or drugs. This technique could lead to faster recovery times and fewer side effects, making it a promising alternative to existing options.
What evidence suggests that low-intensity focused ultrasound is effective for disorders of consciousness?
Research shows that low-intensity focused ultrasound (LIFUP), which participants in this trial will receive, could aid individuals with consciousness disorders following a severe brain injury. Studies have found that LIFUP can increase alertness, enhance language comprehension, and improve the ability to follow commands. Some patients also showed better communication skills. Another study found that LIFUP might be particularly beneficial for those with severe traumatic brain injuries and consciousness disorders. Although challenges and mixed results persist in certain trials, the potential benefits of LIFUP make it a treatment worth considering for aiding recovery in these patients.14678
Are You a Good Fit for This Trial?
This trial is for patients who have severe brain injuries and are not fully recovering, leading to conditions like coma or vegetative state. It's aimed at those with altered consciousness due to injury or stroke.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-intensity focused ultrasound (LIFUP) intervention, along with advanced MRI and EEG assessments
Follow-up
Participants are monitored for neurobehavioral and neurophysiologic responses post-treatment
Ethical Evaluation
Family members or surrogate decision-makers are engaged in interviews to evaluate ethical perspectives surrounding neuromodulation technologies
What Are the Treatments Tested in This Trial?
Interventions
- Low-intensity focused ultrasound
Trial Overview
The study tests low-intensity focused ultrasound (LIFUP) as a treatment to promote recovery in patients with disorders of consciousness after brain injury. It will assess behavioral and EEG responses, along with ethical perspectives from patient representatives.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive low-intensity focused ultrasound intervention. Participants are also anticipated to undergo advanced MRI and EEG. Surrogate decision makers (family members) and recovered patients will undergo a semi-structured interview.
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
Low-Intensity Focused Ultrasound on Individuals With ...
Low-intensity focused ultrasound can be effective in severe TBI patients with disorder of consciousness. This study is a prospective single arm, open-label ...
A Comprehensive Review of Low-Intensity Focused ...
In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound technology, comparing it ...
Progress in Noninvasive Low-Intensity Focused Ultrasound ...
This review discusses the recent and ongoing developments of low-intensity focused ultrasound for neurological regulation.
Low Intensity Focused Ultrasound for Non-invasive and ...
Using MRI-guided LIFU, they observed improved alertness, language comprehension, response to commands, and reliable communication (30) following ...
The efficacy and safety of low-intensity focused ultrasound ...
Recent randomized controlled trials (RCTs) in patients with prolonged disorders of consciousness (pDoC) have yielded limited success.
NCT04306601 | Low-Intensity Focused Ultrasound on ...
This study is a prospective single arm, open-label and explorative clinical trial to evaluate the therapeutic effect of recovery from DoC and safety of low- ...
The efficacy and safety of low-intensity focused ultrasound ...
The efficacy and safety of low-intensity focused ultrasound pulses for prolonged disorders of consciousness: a study protocol for a randomized ...
A retrospective qualitative report of symptoms and safety ...
We provide an evaluation of the safety of LIFU for human neuromodulation through participant report and neurological assessment with a comparison of ...
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