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

Trial Summary

What is the purpose of this trial?

This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.

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 data supports the effectiveness of the treatment Breathing task, Respiratory Exercise, Breathing Exercise, Respiratory Therapy, Transcutaneous vagal nerve stimulation, Transcutaneous Vagus Nerve Stimulation, tVNS?

Research shows that transcutaneous vagus nerve stimulation (tVNS) can be effective for conditions like treatment-resistant depression and may improve brain function in people with severe traumatic brain injury. This suggests that tVNS might help with brain-related issues, which could be relevant to the study of brain fluid imaging during breathing tasks. ^{1 2 3 4 5}

Is transcutaneous vagus nerve stimulation (tVNS) safe for humans?

Transcutaneous vagus nerve stimulation (tVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. It does not require surgery and has a good safety profile, making it suitable for a wide range of uses, including in children. ^{1 2 6 7 8}

How is the MRI Brain Fluid Imaging During Breathing Tasks treatment different from other treatments?

This treatment is unique because it uses MRI to study brain fluid changes during breathing tasks, which is not a standard approach for conditions typically treated with vagus nerve stimulation. It focuses on non-invasive imaging to understand brain responses, unlike traditional treatments that may involve implantable devices or direct nerve stimulation. ^{3 4 5 9 10}

Research Team

Laura Lewis, PhD

Principal Investigator

Boston University

Eligibility Criteria

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).

Inclusion Criteria

I am between 18 and 70 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Vagus Nerve Stimulation in Patients With Severe Traumatic Brain Injury: A Feasibility Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

3. United States 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. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve immediate stimulation treatment for treatment-resistant depression: A functional magnetic resonance imaging study. [2022]

5. Switzerland 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of sub-threshold transcutaneous auricular vagus nerve stimulation on cerebral blood flow. [2022]

10. United States 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. [2020]