TMS-evoked Potentials During Aerobic Exercise (TMS-EEGxercise)

February 4, 2025 updated by: Enrico De Martino, Aalborg University

The Effect of Aerobic Exercise on Brain Connectivity

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nordjylland
      • Gistrup, Nordjylland, Denmark, 9260
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise
30 minutes of aerobic exercise will be performed by the participants before and after cortical connectivity measurements.
30 minutes of aerobic exercise on a stationary bike

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical connectivity
Time Frame: Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)
Global and local mean field amplitude
Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical excitability
Time Frame: Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
TMS-evoked potentials
Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Actual)

February 4, 2025

Study Completion (Actual)

February 4, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • N-20210047-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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