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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06084455
Other study ID # N-20210047-4
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Aalborg University
Contact Enrico De Martino
Phone +4591811183
Email edm@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the modification of the local-to-global connectivity pattern in response to a session of aerobic exercise. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity and connectivity to TMS.


Description:

Chronic musculoskeletal pain disorders rank second only to mental and behavioural disorders as a major contributor to worldwide years lived with disability. Chronic musculoskeletal pain restricts mobility, decreases cardiorespiratory capacity and musculoskeletal function, and ultimately reduces exercise capacity and quality of life. Thus, there is an urgent need for new, effective, and affordable strategies to address this growing problem, particularly in health systems around the world. Abnormal brain connectivity patterns disrupt normal brain function in a specific neural network, causing brain circuit malfunctions and resulting in symptoms such as chronic pain. The advent of electroencephalography (EEG) compatible with transcranial magnetic stimulation (TMS-EEG) has allowed the measurement of the cortical excitability and connectivity of a single pulse of TMS in any scalp region, providing insights into cortical excitability and connectivity that were not previously possible with techniques exclusively based on MEP, create a map of activation caused by a localized pulse of stimulation. Furthermore, TMS-EEG allows recording the spread and the characteristics of the perturbations caused by a single TMS pulse across the cortex (recorded by several electrodes from an EEG cap). Physical exercise has been shown to have a positive impact on brain functioning. Regular exercise promotes the growth of new brain cells and improves the survival of existing ones. Studies have shown that regular exercise improves cognitive function, memory, and mood, and exercise has been linked to increased production of neurotransmitters, hormones, and growth factors that promote brain health. However, to date, no studies have investigated the effect of aerobic exercise on brain excitability and connectivity.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy men and women - Speak and understand English Exclusion Criteria: - Drug addiction defined as the use of cannabis, opioids or other drugs - Previous neurologic, musculoskeletal or mental illnesses - Lack of ability to cooperate - History of chronic pain or current acute pain - Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.). - Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise
30 minutes of aerobic exercise on a stationary bike

Locations

Country Name City State
Denmark Aalborg University Gistrup Nordjylland

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cortical connectivity Global and local mean field amplitude Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)
Secondary Cortical excitability TMS-evoked potentials Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
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