MRI Brain Fluid Imaging During Breathing Tasks

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Laura Lewis, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston University Charles River Campus

Must not be taking: Brain function medications

Disqualifiers: Neurological, Psychiatric, Cardiovascular, others

No Placebo Group

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.

Trial 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 (Behavioral Intervention)
• Transcutaneous vagal nerve stimulation (Procedure)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Boston University - Charles River Campus Boston, MA

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Patients Recruited

14,100+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Patients Recruited

677,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]