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Imaging Brain Fluids During Breathing

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05180981
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
80
Enrollment
2
Locations
2
Arms
51.4
Anticipated Duration (Months)
40
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcutaneous vagal nerve stimulation
  • Behavioral: Breathing task
 N/A

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 MRI scans will take place in the 7 Tesla MRI scanner at Massachusetts General Hospital.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology
Actual Study Start Date :
Jan 18, 2022
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breath task

Participants will breathe in specific patterns.

Behavioral: Breathing task
Participants will be asked to breathe in specific patterns.
Experimental: Transcutaneous vagal nerve stimulation

Participants will receive transcutaneous vagal nerve stimulation in specific patterns.

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.

Outcome Measures

Primary Outcome Measures

  1. functional magnetic resonance imaging (fMRI) signals [During study (2 hours)]

    fMRI measures of hemodynamic responses. Units: percent signal change

  2. Cerebrospinal fluid (CSF) signals [During study (2 hours)]

    MR-based measures of CSF signals. Units: percent signal change

Secondary Outcome Measures

  1. Heart rate [During study ( 2 hours)]

    Heart rate variability will be calculated. Units: milliseconds (ms)

  2. Pulse oximetry [During study ( 2 hours)]

    Amplitude of pulse oximetry signal. Units: arbitrary (no physical units are output by this system)

  3. Respiratory physiology timing [During study (2 hours)]

    Breath timing. Units: Hertz (Hz)

  4. Respiratory physiology amplitude [During study (2 hours)]

    Breath amplitude. Units: arbitrary (no physical units output by this sensor)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 Boston University - Charles River Campus Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Boston University Charles River Campus
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Laura Lewis, PhD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Lewis, Assistant Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT05180981
Other Study ID Numbers:
  • 6029E
  • R01AT011429
First Posted:
Jan 6, 2022
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laura Lewis, Assistant Professor, Boston University Charles River Campus
Glymphatics
Cerebrospinal fluid

Study Results

No Results Posted as of Mar 25, 2022