Imaging Brain Fluids During Breathing

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180981
• Other study ID #: 6029E
• Secondary ID: R01AT011429
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2023
• Source: Boston University Charles River Campus
• Contact: Jessica Yee, BS
• Phone: 7742852038
• Email: jessyee[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Transcutaneous vagal nerve stimulation
Noninvasive stimulation vs sham stimulation will be delivered via an auricular device.

Behavioral:
• Breathing task
Participants will be asked to breathe in specific patterns.

Locations

Country	Name	City	State
United States	Boston University - Charles River Campus	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional magnetic resonance imaging (fMRI) signals	fMRI measures of hemodynamic responses. Units: percent signal change	During study (2 hours)
Primary	Cerebrospinal fluid (CSF) signals	MR-based measures of CSF signals. Units: percent signal change	During study (2 hours)
Secondary	Heart rate	Heart rate variability will be calculated. Units: milliseconds (ms)	During study ( 2 hours)
Secondary	Pulse oximetry	Amplitude of pulse oximetry signal. Units: arbitrary (no physical units are output by this system)	During study ( 2 hours)
Secondary	Respiratory physiology timing	Breath timing. Units: Hertz (Hz)	During study (2 hours)
Secondary	Respiratory physiology amplitude	Breath amplitude. Units: arbitrary (no physical units output by this sensor)	During study (2 hours)