Imaging Brain Fluids During Breathing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2026-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Breath task

Participants will breathe in specific patterns.

Group Type EXPERIMENTAL

Breathing task

Intervention Type BEHAVIORAL

Participants will be asked to breathe in specific patterns.

Transcutaneous vagal nerve stimulation

Participants will receive transcutaneous vagal nerve stimulation in specific patterns.

Group Type EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

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

Breathing task

Intervention Type BEHAVIORAL

Participants will be asked to breathe in specific patterns.

Interventions

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Transcutaneous vagal nerve stimulation

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

Intervention Type DEVICE

Breathing task

Participants will be asked to breathe in specific patterns.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes