Aerobic ExerciseNCT07058584
Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation
A study testing repetitive Transcranial Magnetic Stimulation in people with Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation (rTMS), run by Aalborg University at 1 site in Denmark.
Trial summary
Participants attend two sessions, one week apart, as part of a randomized crossover study involving either an active or sham intervention. Both sessions follow identical procedures, except for the TMS intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Repetitive Transcranial Magnetic Stimulation (rTMS)
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 31 May 2026
- 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 aged 18-60 years
- Speak and understand English
Who cannot join
- Pregnant or breastfeeding
- Regular use of cannabis, opioids, or other drugs
- Chronic pain (i.e., pain most days within the last three months)
- Current or previous neurologic or musculoskeletal illnesses, psychiatric diagnoses, or other ilnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.)
- Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
- Recent history of acute pain (i.e., episodic migraine attacks or pain in the lower limbs)
Show all 11Show fewer
- Abnormally disrupted sleep in 24 hours preceding experiment
- Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
- Unable to fulfil the criteria of the "Transcranial Magnetic Stimulation Adult Safety Screen"
- Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos.
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation on Brain Connectivity and Pain Sensitivity
Participants attend two sessions, one week apart, as part of a randomized crossover study involving either an active or sham intervention. Both sessions follow identical procedures, except for the TMS intervention. Each session includes: three pain pressure threshold measurements, two TMS-EEG recordings, 30 minutes of moderate-intensity exercise on a stationary bike, and two resting-state EEG recordings. Repetitive TMS is administered as an active intervention in one session and as a sham in the other, and more.
- Being tested
- repetitive Transcranial Magnetic Stimulation, Sham repetitive Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
Repetitive transcranial magnetic stimulation (rTMS) is administered using a figure-of-eight coil from MagVenture positioned over the left primary motor cortex (M1) in an anteroposterior direction. High-frequency rTMS is delivered at 10 Hz, consisting of 100 trains of 10-second duration (3000 pulses), with 20-second inter-train intervals, at ~90% of resting motor threshold (RMT) depending on participant tolerance and TMS-EEG brain response.
Sham repetitive Transcranial Magnetic StimulationDevice
This intervention involves high-frequency repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1), using a figure-of-eight coil. In the sham condition, the same coil is used, but it is oriented away from the scalp at an angle that prevents effective magnetic stimulation of the brain, while still producing similar auditory and tactile sensations. This allows participants to remain blinded to the intervention type, maintaining the single-blind nature of the study. The active stimulation is delivered at 10 Hz, comprising 30 trains of 10 seconds (9900 milliseconds)(3000 pulses in total), with 20-second inter-train intervals, at ~110% of the individual's resting motor threshold (rMT). Stimulation is delivered while the participant is seated at rest, and the full rTMS protocol takes approximately 15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise & rTMS | Experimental | Each session includes identical procedures, except for the type of repetitive transcranial magnetic stimulation (rTMS) administered. Participants receive active rTMS in one session and sham rTMS in the other, with the order randomized. The intervention arm includes the following procedures (not in order):
Pain pressure threshold (PPT) assessments performed three times per session
TMS-EEG data collection conducted at two time points per session
30 minutes of moderate-intensity cycling on a stationary bike
Resting-state EEG recorded twice per session
Repetitive TMS intervention: active stimulation in one session, sham stimulation in the other Receives: Device: repetitive Transcranial Magnetic Stimulation; Device: Sham repetitive Transcranial Magnetic Stimulation |
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: Day 1
Cortical connectivity
Global and local mean field amplitude
Measured: Day 2
Secondary outcomes (8)
Pain Pressure Threshold
Pain Pressure Threshold in kPa will be measured 3 times per session using handheld algometer.
Measured: Day 1
Pain Pressure Threshold
Pain Pressure Threshold in kPa will be measured 3 times per session using handheld algometer.
Measured: Day 2
Cortical excitability
TMS-evoked potentials from the TMS-EEG.
Measured: Day 1
Cortical excitability
TMS-evoked potentials from the TMS-EEG.
Measured: Day 2
Borg-20
Questionnaire for subjective fatique level on a scale from 6 to 20, where 6 is rest and 20 is maximal exertion. We will ask the rating at different timepoints during the 30 minutes exercise.
Measured: Day 1
Borg-20
Questionnaire for subjective fatique level on a scale from 6 to 20, where 6 is rest and 20 is maximal exertion. We will ask the rating at different timepoints during the 30 minutes exercise.
Measured: Day 2
Pain Numerical Rating Scale (NRS)
The subject will be asked to rate their pain during exercise on an NRS ranging from 0 to 10 with 0 corresponding to no pain and 10 corresponding to worst imaginable pain. We will ask the rating at different timepoints during the 30 minutes exercise.
Measured: Day 1
Pain Numerical Rating Scale (NRS)
The subject will be asked to rate their pain during exercise on an NRS ranging from 0 to 10 with 0 corresponding to no pain and 10 corresponding to worst imaginable pain. We will ask the rating at different timepoints during the 30 minutes exercise.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Apr 2025
- Primary completion30 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants attend two laboratory sessions scheduled one week apart, as part of a randomized, crossover study. In this design, each participant receives both conditions - an active and a sham repetitive transcranial magnetic stimulation (rTMS) intervention - in a randomized order. This within-subject crossover approach allows each participant to serve as their own control, improving statistical power and reducing the influence of inter-individual variability.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
- Investigators
- Enrico De Martino, MD, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058584
- Sponsor's protocol ID
- N-20240053 - Study 2
- Status last verified
- May 2026
- First submitted
- 1 Jul 2025
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation on Brain Connectivity and Pain Sensitivity
- ClinicalTrials.gov ID
- NCT07058584
- Acronym / sponsor ID
- N-20240053 - Study 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 10 Jul 2025 (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.
Participants attend two sessions, one week apart, as part of a randomized crossover study involving either an active or sham intervention. Both sessions follow identical procedures, except for the TMS intervention. Each session includes: three pain pressure threshold measurements, two TMS-EEG recordings, 30 minutes of moderate-intensity exercise on a stationary bike, and two resting-state EEG recordings. Repetitive TMS is administered as an active intervention in one session and as a sham in the other, and more.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants attend two laboratory sessions scheduled one week apart, as part of a randomized, crossover study. In this design, each participant receives both conditions - an active and a sham repetitive transcranial magnetic stimulation (rTMS) intervention - in a randomized order. This within-subject crossover approach allows each participant to serve as their own control, improving statistical power and reducing the influence of inter-individual variability.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise & rTMS | Experimental | Device: repetitive Transcranial Magnetic Stimulation, Device: Sham repetitive Transcranial Magnetic StimulationEach session includes identical procedures, except for the type of repetitive transcranial magnetic stimulation (rTMS) administered. Participants receive active rTMS in one session and sham rTMS in the other, with the order randomized. The intervention arm includes the following procedures (not in order): Pain pressure threshold (PPT) assessments performed three times per session TMS-EEG data collection conducted at two time points per session 30 minutes of moderate-intensity cycling on a stationary bike Resting-state EEG recorded twice per session Repetitive TMS intervention: active stimulation in one session, sham stimulation in the other |
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 aged 18-60 years
- Speak and understand English
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Regular use of cannabis, opioids, or other drugs
- Chronic pain (i.e., pain most days within the last three months)
- Current or previous neurologic or musculoskeletal illnesses, psychiatric diagnoses, or other ilnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.)
- Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
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 |
|---|---|---|
| repetitive Transcranial Magnetic StimulationRepetitive transcranial magnetic stimulation (rTMS) is administered using a figure-of-eight coil from MagVenture positioned over the left primary motor cortex (M1) in an anteroposterior direction. High-frequency rTMS is delivered at 10 Hz, consisting of 100 trains of 10-second duration (3000 pulses), with 20-second inter-train intervals, at ~90% of resting motor threshold (RMT) depending on participant tolerance and TMS-EEG brain response. | Device | Aerobic Exercise & rTMS |
| Sham repetitive Transcranial Magnetic StimulationThis intervention involves high-frequency repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1), using a figure-of-eight coil. In the sham condition, the same coil is used, but it is oriented away from the scalp at an angle that prevents effective magnetic stimulation of the brain, while still producing similar auditory and tactile sensations. This allows participants to remain blinded to the intervention type, maintaining the single-blind nature of the study. The active stimulation is delivered at 10 Hz, comprising 30 trains of 10 seconds (9900 milliseconds)(3000 pulses in total), with 20-second inter-train intervals, at ~110% of the individual's resting motor threshold (rMT). Stimulation is delivered while the participant is seated at rest, and the full rTMS protocol takes approximately 15 minutes to complete. | Device | Aerobic Exercise & rTMS |
Primary outcome
Cortical connectivity
Time frame: Day 1
Global and local mean field amplitude
Cortical connectivity
Time frame: Day 2
Global and local mean field amplitude
8 secondary outcomes
Pain Pressure Threshold
Time frame: Day 1
Pain Pressure Threshold
Time frame: Day 2
Cortical excitability
Time frame: Day 1
Cortical excitability
Time frame: Day 2
Borg-20
Time frame: Day 1
Borg-20
Time frame: Day 2
Pain Numerical Rating Scale (NRS)
Time frame: Day 1
Pain Numerical Rating Scale (NRS)
Time frame: Day 2
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 2 Jun 2026.
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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.
Enrico De Martino, MD, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation (rTMS), 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 11 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 2 Jun 2026. 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: Day 1). The study lists 2 primary outcomes in all. 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 2 Jun 2026.