Imaging Brain Fluids During Breathing

Boston University Charles River Campus

Status: Enrolling

Conditions: Healthy

Treatments: Behavioral: Breathing task; Device: Transcutaneous vagal nerve stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05180981

6029E

R01AT011429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Breath task

Experimental group

Description:

Participants will breathe in specific patterns.

Treatment:

Behavioral: Breathing task

Transcutaneous vagal nerve stimulation

Experimental group

Description:

Participants will receive transcutaneous vagal nerve stimulation in specific patterns.

Treatment:

Device: Transcutaneous vagal nerve stimulation

Behavioral: Breathing task