LIFU for Autonomic Nervous System Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates how low-intensity focused ultrasound (LIFU) neuromodulation affects the autonomic nervous system, which manages automatic body functions like heart rate and digestion. Researchers are testing LIFU on two brain areas: the dorsal posterior insula (dPI) and the dorsal anterior cingulate cortex (dACC), while comparing results to a placebo-like sham group. Participants will complete a cold pressor task (a test involving cold exposure) before and after LIFU to assess changes in their body's automatic responses. Individuals without neurological disorders or major heart or diabetes issues may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on LIFU's effects on the nervous system.
Will I have to stop taking my current medications?
The trial requires that you have not used any cardiac or diabetic medications, so if you are currently taking these, you would need to stop before participating.
What prior data suggests that this method is safe for autonomic nervous system disorders?
Research has shown that low-intensity focused ultrasound (LIFU) is emerging as a promising treatment for various mental health conditions. Studies have found that LIFU is usually well-tolerated, with patients experiencing few side effects. One study on severe traumatic brain injury used LIFU safely without major problems.
Although researchers continue to study LIFU, its use in other brain regions hasn't raised significant safety concerns. This suggests it might also be safe for the areas targeted in this trial: the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC). However, since this trial is in its early stages, more information is needed to fully confirm its safety for these specific areas.12345Why are researchers excited about this trial?
Researchers are excited about low-intensity focused ultrasound (LIFU) neuromodulation for autonomic nervous system disorders because it offers a non-invasive approach to modulating brain activity, unlike standard treatments that typically involve medication or invasive procedures. LIFU targets specific areas of the brain, such as the anterior cingulate cortex (ACC) and the dorsal prefrontal insula (dPI), using sound waves to potentially alter neural circuits without the need for surgery. This precision targeting could lead to fewer side effects and quicker adjustments compared to traditional therapies, providing a novel pathway to manage symptoms more effectively.
What evidence suggests that Low-intensity focused ultrasound neuromodulation is effective for autonomic nervous system disorders?
This trial will explore the effects of low-intensity focused ultrasound (LIFU) for autonomic nervous system disorders. Participants will be assigned to different treatment arms: LIFU targeting the ACC, LIFU targeting the dPI, or a sham LIFU application. Studies have shown that LIFU is gaining popularity for treating various brain-related conditions. For instance, LIFU has been used successfully in patients with severe traumatic brain injury to help them regain consciousness. Other research found that LIFU can reduce pain by about 1 point on a 10-point scale and alter the body's reaction to pain. Overall, LIFU is a noninvasive method, meaning it doesn't require surgery, and it shows promise for positively affecting brain activity.12346
Are You a Good Fit for This Trial?
This trial is for individuals with autonomic nervous system disorders who don't have claustrophobia, metal implants incompatible with MRI or CT scans, active CNS-affecting medical conditions, a history of significant head injury, substance dependence, or cardiac disease.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 (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) to study autonomic control
Follow-up
Participants are monitored for changes in sympathetic tone response through EEG, HRV, HR, BP, and EDR
What Are the Treatments Tested in This Trial?
Interventions
- Low-intensity focused ultrasound neuromodulation
Trial Overview
The study tests if Low Intensity Focused Ultrasound (LIFU) targeting specific brain areas affects the body's automatic functions. Participants undergo cold pressor task, valsalva maneuver and deep breathing tasks before and after LIFU to measure changes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
LIFU to the dPI
LIFU to the ACC
Sham LIFU application
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State University
Lead Sponsor
Citations
A Comprehensive Review of Low-Intensity Focused ...
Low-intensity focused ultrasound (LIFU) is gaining increased interest as a potential therapeutic modality for a range of neuropsychiatric diseases.
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, ...
NCT04306601 | Low-Intensity Focused Ultrasound on ...
Low-intensity focused ultrasound can be effective in severe TBI patients with disorder of consciousness. This study is a prospective single arm, ...
4.
fusfoundation.org
fusfoundation.org/posts/treating-pain-with-focused-ultrasound-two-neuromodulation-clinical-trials/Two Neuromodulation Clinical Trials
LIFU noninvasively reduced pain by roughly 1 point on a 10 point scale and altered autonomic responses to the painful stimuli. See the Journal ...
Examination of low-intensity focused ultrasound ...
Conclusions LIFU to M1 in humans, in the range employed, either conferred inhibition or had no effect. Significant excitation was not observed.
Low-intensity focused ultrasound of the spine in ...
In this work, we review current advances in LIFU of the spine region for the treatment of chronic neuropathic pain and movement disorders.
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