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Clinical Trials/NCT05180981
NCT05180981
Recruiting
Not Applicable

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

Boston University Charles River Campus2 sites in 1 country80 target enrollmentJanuary 18, 2022
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Boston University Charles River Campus
Enrollment
80
Locations
2
Primary Endpoint
functional magnetic resonance imaging (fMRI) signals
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2022
End Date
May 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Laura Lewis

Assistant Professor

Boston University Charles River Campus

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Pulse oximetry(During study ( 2 hours))
  • Heart rate(During study ( 2 hours))
  • Respiratory physiology timing(During study (2 hours))
  • Respiratory physiology amplitude(During study (2 hours))

Study Sites (2)

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