Imaging brain fluids during breathing tasks
Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology
NA · Boston University Charles River Campus · NCT05180981
This study is testing how different breathing patterns and a nerve stimulation technique affect the flow of fluid around the brain in people to learn more about brain health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Boston University Charles River Campus (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05180981 on ClinicalTrials.gov |
What this trial studies
This study investigates how breathing patterns affect the flow of cerebrospinal fluid (CSF) around the brain using high-resolution magnetic resonance imaging (MRI). Participants will engage in specific breathing tasks or receive transcutaneous vagal nerve stimulation while undergoing MRI scans. The goal is to understand the relationship between breathing and CSF dynamics, which are crucial for brain health. The study will involve two groups: one focusing on paced breathing and the other on vagal nerve stimulation, with imaging conducted at Massachusetts General Hospital.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-70 without neurological or psychiatric disorders.
Not a fit: Patients with major head trauma, neurological or psychiatric disorders, or those with implanted electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of brain health and the role of breathing in cerebrospinal fluid dynamics.
How similar studies have performed: While the specific approach of imaging CSF flow during breathing is novel, related studies on CSF dynamics have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult age 18-70 years Exclusion Criteria: * No ferrous metal implanted in head or body * No history of major head trauma * No neurological or psychiatric disorder * Not using medication that affects brain function * No implanted electronic devices (e.g. pacemaker) * No implant that poses an MR contraindication * Not pregnant, suspect they are pregnant, or seeking to become pregnant * Not claustrophobic * No piercings or jewelry that cannot be removed * Does not weigh more than 250 pounds * Normal or contact-corrected normal vision Exclusion for transcutaneous vagus nerve stimulation (tVNS) arm: * Conditions of skin or anatomy that affect left auricle or forehead skin and could impact placement of electrodes for tVNS or forehead stimulation * Diagnosis of significant cardiovascular or cerebrovascular disease \[e.g. congestive heart failure, stroke, cardiac conduction disorders (including: bundle branch block, heart block, long Q-T syndrome), history of asystole or non-sustained ventricular tachycardia. * Bradycardia (defined as resting heart rate \<50 bpm) * Hypotension defined as blood pressure \<90/60 mmHg
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Boston University - Charles River Campus — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Laura Lewis, PhD — Boston University
- Study coordinator: Jessica Yee, BS
- Email: jessyee@bu.edu
- Phone: 7742852038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, Glymphatics, Cerebrospinal fluid