NCT05180981

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.3 years

First QC Date

November 3, 2021

Last Update Submit

June 14, 2023

Conditions

Healthy

Keywords

GlymphaticsCerebrospinal fluid

Outcome Measures

Primary Outcomes (2)

  • functional magnetic resonance imaging (fMRI) signals

    fMRI measures of hemodynamic responses. Units: percent signal change

    During study (2 hours)

  • Cerebrospinal fluid (CSF) signals

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

    During study (2 hours)

Secondary Outcomes (4)

  • Heart rate

    During study ( 2 hours)

  • Pulse oximetry

    During study ( 2 hours)

  • Respiratory physiology timing

    During study (2 hours)

  • Respiratory physiology amplitude

    During study (2 hours)

Study Arms (2)

Breath task

EXPERIMENTAL

Participants will breathe in specific patterns.

Behavioral: Breathing task

Transcutaneous vagal nerve stimulation

EXPERIMENTAL

Participants will receive transcutaneous vagal nerve stimulation in specific patterns.

Device: Transcutaneous vagal nerve stimulationBehavioral: Breathing task

Interventions

Transcutaneous vagal nerve stimulationDEVICE

Noninvasive stimulation vs sham stimulation will be delivered via an auricular device.

Transcutaneous vagal nerve stimulation
Breathing taskBEHAVIORAL

Participants will be asked to breathe in specific patterns.

Breath taskTranscutaneous vagal nerve stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult age 18-70 years

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston University - Charles River Campus

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

  • Laura Lewis, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yee, BS

CONTACT

7742852038jessyee@bu.edu

Courtney Zambello, BA

CONTACT

7812019815cgz@bu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 3, 2021

First Posted

January 6, 2022

Study Start

January 18, 2022

Primary Completion

April 30, 2026

Study Completion

May 1, 2026

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(2)