MRI Brain Fluid Imaging During Breathing Tasks

Recruiting at 1 trial location

Overseen By Courtney Zambello, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must not be taking: Brain function medications

Disqualifiers: Neurological, Psychiatric, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different breathing patterns and gentle nerve stimulation affect brain fluid flow and blood movement. Researchers aim to determine if these tasks can alter fluid movement in the brain, potentially aiding future treatments for brain conditions. Participants will either practice specific breathing techniques, known as "breathing tasks," or receive a safe, non-invasive nerve stimulation called transcutaneous vagal nerve stimulation. This trial suits adults without head trauma or certain health conditions and who have no metal implants or devices in their body. As an unphased trial, it offers participants the chance to contribute to foundational research that could lead to innovative treatments for brain health.

Will I have to stop taking my current medications?

The trial requires that you are not using medication that affects brain function, so you may need to stop taking such medications.

What prior data suggests that these techniques are safe?

Research has shown that the breathing exercises used during MRIs are generally safe. Following specific breathing patterns aids brain imaging without causing harm. These exercises resemble holding one's breath for short periods, which most people can do without issues.

For transcutaneous vagal nerve stimulation (tVNS), studies suggest it is safe and well-tolerated. This technique uses gentle electrical currents on the skin to stimulate a nerve in the neck. Research has found it to be non-invasive and generally safe, even in situations like stroke treatment. Overall, previous studies have shown both treatments in the trial to be low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how specific breathing tasks and transcutaneous vagal nerve stimulation can impact brain fluid dynamics. Unlike traditional methods that might focus on medication or invasive procedures, this trial uses non-invasive techniques to potentially influence brain health. The breathing tasks involve specific patterns that could optimize oxygen flow and affect brain fluid movement, while the vagal nerve stimulation uses electrical impulses through the skin to potentially regulate brain activity. These innovative approaches aim to uncover new ways to enhance brain function and health without the need for drugs or surgery.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of two different interventions on brain fluid dynamics. Participants in one arm will perform specific breathing tasks. Research has shown that certain breathing exercises can affect the flow of cerebrospinal fluid (CSF) in the brain. One study found that breathing challenges can improve CSF movement, potentially benefiting brain health. Additionally, deep breathing reduced blood flow in the brain by 29%, indicating a significant effect on brain function.

In another arm, participants will receive transcutaneous vagal nerve stimulation (tVNS). Research indicates that tVNS can boost brain plasticity, helping the brain adapt and function better. tVNS has also successfully treated conditions like depression and epilepsy by altering brain activity and connections. These treatments are non-invasive and may improve brain health and function. ^{6 7 8 9 10}

Who Is on the Research Team?

Laura Lewis, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 who are not on brain-affecting meds, have no serious heart or brain conditions, no metal implants, and aren't pregnant. Participants must be under 250 pounds without claustrophobia and should have normal vision (with contacts if needed).

Exclusion Criteria

No history of major head trauma

My vision is normal, with or without contacts.

I am not on medication that affects my brain function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Study Visit

Participants undergo MRI scans while performing breathing tasks or receiving vagal nerve stimulation

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging study

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breathing task
• Transcutaneous vagal nerve stimulation

Trial Overview The study tests how breathing exercises and non-invasive nerve stimulation affect the flow of fluids in the brain using MRI scans. It aims to understand changes in blood flow and fluid dynamics during different breathing tasks.

How Is the Trial Designed?

Group I: Transcutaneous vagal nerve stimulation Experimental Treatment 2 Interventions

Participants will receive transcutaneous vagal nerve stimulation in specific patterns.

Group II: Breath task Experimental Treatment 1 Intervention

Participants will breathe in specific patterns.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Transcutaneous cervical vagus nerve stimulation (tcVNS) significantly increased motor cortex excitability in healthy adults, as evidenced by a notable increase in motor-evoked potential (MEP) amplitude after real stimulation compared to sham stimulation.

The study involved 28 healthy participants and demonstrated that real tcVNS not only increased MEP amplitude but also decreased MEP latency, indicating a faster response time in the motor cortex, while no significant changes were observed in the resting motor threshold.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous cervical vagus nerve stimulation improved motor cortex excitability in healthy adults: a randomized, single-blind, self-crossover design study. Wang, MX., Wumiti, A., Zhang, YW., et al.[2023]

Using 7T fMRI, the study found that transcutaneous auricular vagus nerve stimulation (taVNS) applied during exhalation (eRAVANS) significantly increased brain activity in areas associated with autonomic regulation, particularly the nucleus tractus solitarii (NTS), compared to stimulation during inhalation (iRAVANS).

eRAVANS not only enhanced brainstem responses but also improved cardiovagal modulation, indicating that the timing of taVNS application can optimize its effects on both central nervous system activity and heart rate regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of respiration on brainstem and cardiovagal response to auricular vagus nerve stimulation: A multimodal ultrahigh-field (7T) fMRI study. Sclocco, R., Garcia, RG., Kettner, NW., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) has been shown to effectively modulate brain activity in patients with treatment-resistant depression (TRD), as evidenced by significant changes in brain regions such as the medial orbital frontal cortex after just 30 minutes of stimulation.

The study utilized rest-state functional magnetic resonance imaging (rs-fMRI) with 40 TRD patients and 40 healthy controls, revealing that taVNS may alter functional connectivity in key cortical areas, suggesting potential neural mechanisms for its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve immediate stimulation treatment for treatment-resistant depression: A functional magnetic resonance imaging study. Ma, Y., Wang, Z., He, J., et al.[2022]

High-frequency sub-threshold transcutaneous auricular vagus nerve stimulation (taVNS) significantly decreased cerebral blood flow (CBF) in the posterior cerebellum of 20 healthy subjects, indicating a potential mechanism of action for its therapeutic effects.

This study provides a foundation for future research on taVNS in clinical populations and supports the use of arterial spin labeling (ASL) MRI to assess the sustained effects of taVNS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sub-threshold transcutaneous auricular vagus nerve stimulation on cerebral blood flow. Chen, C., Mao, Y., Falahpour, M., et al.[2022]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Vagus nerve stimulation (VNS) is effective for treating refractory epilepsy and depression, but traditional methods involve surgical implantation, which carries risks such as infection and bradycardia.

New non-invasive VNS systems eliminate the need for surgery, improving safety and tolerability, and allowing patients to administer stimulation on demand, potentially expanding its use in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Ben-Menachem, E., Revesz, D., Simon, BJ., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous vagus nerve stimulation (tVNS) was found to be feasible and safe for patients with persistent impairment of consciousness after severe traumatic brain injury (TBI), with minimal side effects reported during an eight-week treatment period.

Out of five patients treated, three showed significant improvements in consciousness as measured by the Coma Recovery Scale-Revised (CRS-R), suggesting that tVNS may have potential benefits for recovery following severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Vagus Nerve Stimulation in Patients With Severe Traumatic Brain Injury: A Feasibility Trial. Hakon, J., Moghiseh, M., Poulsen, I., et al.[2022]

Transcutaneous vagus nerve stimulation (tVNS) shows promise for treating various conditions in pediatric patients, but current studies lack specific protocols and justification for its use in this age group, as none of the 15 identified studies focused exclusively on children.

There are no dedicated tVNS devices for pediatric use, and existing studies do not adequately address neurodevelopmental considerations, highlighting the need for more research on age-appropriate stimulation parameters and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. Sigrist, C., Torki, B., Bolz, LO., et al.[2023]

Citations

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Cardiac and respiratory activities induce temporal changes ... During deep breathing, compared to free breathing, the total cerebral arterial flow rate decreased by 29 % (from 12.5 ml/s to 8.8 ml/s), and the duration of the ...

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Effects of 12 weeks of head-down strong abdominal ... Highlights. Head-down position and breathing exercises affect cognitive function during DT. The combined intervention may improve patients quality of life. ...

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Using respiratory challenges to modulate CSF movement ... Our results demonstrate that these respiratory challenges enhance the magnitude as well as control the direction of CSF movement in the fourth ventricle.

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Respiratory challenge MRI: Practical aspects - PMC In this paper we review the rationale for respiratory challenge MRI including the effects of oxygen and carbon dioxide on the cerebral circulation. We also ...

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Respiratory Motion Management in Abdominal MRI If a patient can cooperate, breath holding, in a typical duration of 10–20 seconds, is the simplest method for avoiding respiratory motion– ...

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Immediate impact of yogic breathing on pulsatile ... We are interested in identifying potential integrative therapies such as yogic breathing to regulate CSF dynamics, which has not been reported before.