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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04255758
Other study ID # T6/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Turku University Hospital
Contact Ilkka Heinonen, PhD
Phone +358 408 393 962
Email ilkka.heinonen@utu.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates changes in glymphatic flow in the brain acutely after vigorous-intensity steady-state aerobic exercise. Twenty subjects (10 male and 10 female) perform 25 minute submaximal cycle ergometry exercise and the changes in the glymphatic flow and cerebral perfusion are evaluated using a variety of MRI sequences (e.g. MREG).


Description:

The glymphatic system is a drainage system for the brain to help maintain fluid balance and extract waste metabolites. Glymphatic system function (healthy glymphatic flow) may prevent accumulation of harmful substances and therefore slow down the onset of neurodegenerative diseases. The hypothesis is, that glymphatic flow could be increased through exercise and enhanced cerebral arterial pulsality, which might explain some of the brain health benefits of exercise proven in epidemiological studies. This study indirectly investigates the acute changes in the glymphatic flow acutely after aerobic exercise using MREG that measures pulse wave propagation as an indirect surrogate marker for glymphatic flow. Twenty healthy subjects (n=20, 10 male, 10 female, age 18-45 years) will perform 25 minute 70%VO2max cycle ergometry exercise. The glymphatic flow and cerebral perfusion will be measured using magnetic resonance imaging sequences before and after exercise. The glymphatic flow is measured using 10 Hz fMRI technique called magnetic resonance encephalography (MREG). In addition, perfusion MRI is used to evaluate changes in brain perfusion.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Age 18-45 - BMI 18-30 - Resting Blood pressure < 140/90 mmHg Exclusion Criteria: - History of a cardiac event - Insulin or medically treated diabetes - Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results - Presence of ferromagnetic objects that would make MR imaging contraindicated - Claustrophobia - Abundant use of alcohol - Use of narcotics - Smoking of tobacco or consuming snuff tobacco - Diagnosed depressive or bipolar disorder - Abnormalities in resting ECG (revised by the study physician) - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cycle Ergometer Exercise
25 minutes, 70% VO2max steady state cycle ergometry exercise

Locations

Country Name City State
Finland Turku PET Centre Turku

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Rajna Z, Raitamaa L, Tuovinen T, Heikkila J, Kiviniemi V, Seppanen T. 3D Multi-Resolution Optical Flow Analysis of Cardiovascular Pulse Propagation in Human Brain. IEEE Trans Med Imaging. 2019 Sep;38(9):2028-2036. doi: 10.1109/TMI.2019.2904762. Epub 2019 Mar 15. — View Citation

von Holstein-Rathlou S, Petersen NC, Nedergaard M. Voluntary running enhances glymphatic influx in awake behaving, young mice. Neurosci Lett. 2018 Jan 1;662:253-258. doi: 10.1016/j.neulet.2017.10.035. Epub 2017 Oct 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MREG cardiovascular pulse wavefront Is processed into three-dimensional vector fields and used as an assessment of glymphatic flow, scanned once before and multiple times after exercise intervention in 5-minute sequences 3 hours
Secondary Cerebral perfusion fMRI 5-minute MR imaging sequences evaluating changes in blood flow, scanned once before and multiple times after exercise intervention 3 hours
Secondary Heart rate (HR) Wearable heart rate monitoring, measures heart beats per second, continuous throughout the study 3 hours
Secondary Blood pressure (BP) Blood pressure monitoring, evaluates systolic and diastolic pressures (mmHg) continuous throughout the study 3 hours
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