Transcranial Magnetic StimulationTMS-EEGxerciseNCT06084455
TMS-evoked Potentials During Aerobic Exercise
A study testing Aerobic exercise in people with Transcranial Magnetic Stimulation and Electroencephalography, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation, Electroencephalography, Aerobic Exercise
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2023to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Speak and understand English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
30 minutes of aerobic exercise on a stationary bike
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 30 minutes of aerobic exercise will be performed by the participants before and after cortical connectivity measurements. Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical connectivity
Global and local mean field amplitude
Measured: Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)
Secondary outcomes (1)
Cortical excitability
TMS-evoked potentials
Measured: Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Oct 2023
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084455
- Sponsor's protocol ID
- N-20210047-4
- Acronym
- TMS-EEGxercise
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on Brain Connectivity
- ClinicalTrials.gov ID
- NCT06084455
- Acronym / sponsor ID
- TMS-EEGxercise / N-20210047-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exercise30 minutes of aerobic exercise will be performed by the participants before and after cortical connectivity measurements. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Speak and understand English
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise30 minutes of aerobic exercise on a stationary bike | Other | Aerobic exercise |
Primary outcome
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
1 secondary outcome
Cortical excitability
Time frame: Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Transcranial Magnetic Stimulation and Electroencephalography, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical connectivity (time frame: Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.