HealthyNCT05180981
Imaging Brain Fluids During Breathing
A study testing Transcutaneous vagal nerve stimulation and Breathing task in people with Healthy, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcutaneous vagal nerve stimulation and Breathing task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age 18-70 years
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University - Charles River Campus
Boston, Massachusetts, 02215
About this study
Official title: Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology
This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.
Read the 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.
- Conditions
- Healthy
- Being tested
- Transcutaneous vagal nerve stimulation, Breathing task
- Keywords
- Glymphatics, Cerebrospinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagal nerve stimulationDevice
Noninvasive stimulation vs sham stimulation will be delivered via an auricular device.
Breathing taskBehavioural
Participants will be asked to breathe in specific patterns.
| Study group | Role | What they receive |
|---|---|---|
| Breath task | Experimental | Participants will breathe in specific patterns. Receives: Behavioral: Breathing task |
| Transcutaneous vagal nerve stimulation | Experimental | Participants will receive transcutaneous vagal nerve stimulation in specific patterns. Receives: Device: Transcutaneous vagal nerve stimulation; Behavioral: Breathing task |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional magnetic resonance imaging (fMRI) signals
fMRI measures of hemodynamic responses. Units: percent signal change
Measured: During study (2 hours)
Cerebrospinal fluid (CSF) signals
MR-based measures of CSF signals. Units: percent signal change
Measured: During study (2 hours)
Secondary outcomes (4)
Heart rate
Heart rate variability will be calculated. Units: milliseconds (ms)
Measured: During study ( 2 hours)
Pulse oximetry
Amplitude of pulse oximetry signal. Units: arbitrary (no physical units are output by this system)
Measured: During study ( 2 hours)
Respiratory physiology timing
Breath timing. Units: Hertz (Hz)
Measured: During study (2 hours)
Respiratory physiology amplitude
Breath amplitude. Units: arbitrary (no physical units output by this sensor)
Measured: During study (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start18 Jan 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Laura Lewis, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180981
- Sponsor's protocol ID
- 6029E
- Other IDs
- R01AT011429
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology
- ClinicalTrials.gov ID
- NCT05180981
- Acronym / sponsor ID
- 6029E
- Conditions
- Healthy
- Keywords
- Glymphatics, Cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath task | Experimental | Behavioral: Breathing taskParticipants will breathe in specific patterns. |
| Transcutaneous vagal nerve stimulation | Experimental | Device: Transcutaneous vagal nerve stimulation, Behavioral: Breathing taskParticipants will receive transcutaneous vagal nerve stimulation in specific patterns. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult age 18-70 years
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagal nerve stimulationNoninvasive stimulation vs sham stimulation will be delivered via an auricular device. | Device | Transcutaneous vagal nerve stimulation |
| Breathing taskParticipants will be asked to breathe in specific patterns. | Behavioural | Breath task, Transcutaneous vagal nerve stimulation |
Primary outcome
functional magnetic resonance imaging (fMRI) signals
Time frame: During study (2 hours)
fMRI measures of hemodynamic responses. Units: percent signal change
Cerebrospinal fluid (CSF) signals
Time frame: During study (2 hours)
MR-based measures of CSF signals. Units: percent signal change
4 secondary outcomes
Heart rate
Time frame: During study ( 2 hours)
Pulse oximetry
Time frame: During study ( 2 hours)
Respiratory physiology timing
Time frame: During study (2 hours)
Respiratory physiology amplitude
Time frame: During study (2 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Lewis, PhD principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagal nerve stimulation and Breathing task in people with Healthy, run by Boston University Charles River Campus at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional magnetic resonance imaging (fMRI) signals (time frame: During study (2 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.