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Imaging Brain Fluids During Breathing

Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05180981
Enrollment
81
Registered
2022-01-06
Start date
2022-01-18
Completion date
2026-11-01
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Glymphatics, Cerebrospinal fluid

Brief summary

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

Detailed description

Cerebrospinal fluid (CSF) flow is essential for brain health, as it clears waste products from the brain. This study will investigate how breathing affects the flow of CSF around the brain. The investigators will perform high resolution magnetic resonance imaging (MRI) scans in participants who are breathing in specific patterns or performing simple tasks and test the effects on CSF flow. Participants will complete an imaging study visit in which the investigators will image their brain activity while they perform simple tasks, including paced breathing tasks. The participants will be split into two arms: (1) paced breathing (25 participants low resolution, 15 participants high resolution), (2) transcutaneous vagal nerve stimulation (25 participants low resolution, 15 participants high resolution). The MRI scans will take place in the 7 Tesla MRI scanner at Massachusetts General Hospital.

Interventions

Noninvasive stimulation vs sham stimulation will be delivered via an auricular device.

BEHAVIORALBreathing task

Participants will be asked to breathe in specific patterns.

Sponsors

Boston University Charles River Campus
Lead SponsorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
functional magnetic resonance imaging (fMRI) signalsDuring study (2 hours)fMRI measures of hemodynamic responses. Units: percent signal change
Cerebrospinal fluid (CSF) signalsDuring study (2 hours)MR-based measures of CSF signals. Units: percent signal change

Secondary

MeasureTime frameDescription
Heart rateDuring study ( 2 hours)Heart rate variability will be calculated. Units: milliseconds (ms)
Pulse oximetryDuring study ( 2 hours)Amplitude of pulse oximetry signal. Units: arbitrary (no physical units are output by this system)
Respiratory physiology timingDuring study (2 hours)Breath timing. Units: Hertz (Hz)
Respiratory physiology amplitudeDuring study (2 hours)Breath amplitude. Units: arbitrary (no physical units output by this sensor)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura Lewis, PhD

Boston University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026