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Completed

NCT Number: NCT07058584

Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation

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.

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Key information

Conditions

Aerobic Exercise Repetitive Transcranial Magnetic Stimulation (rTMS)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Gistrup, 9260, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women aged 18-60 years
  • Speak and understand English

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 stimulation

Device

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.

Primary outcomes

  1. Cortical connectivity

    Time frame: Day 1

    Global and local mean field amplitude

  2. Cortical connectivity

    Time frame: Day 2

    Global and local mean field amplitude

Secondary outcomes

  1. Pain Pressure Threshold

    Time frame: Day 1

    Pain Pressure Threshold in kPa will be measured 3 times per session using handheld algometer.

  2. Pain Pressure Threshold

    Time frame: Day 2

    Pain Pressure Threshold in kPa will be measured 3 times per session using handheld algometer.

  3. Cortical excitability

    Time frame: Day 1

    TMS-evoked potentials from the TMS-EEG.

  4. Cortical excitability

    Time frame: Day 2

    TMS-evoked potentials from the TMS-EEG.

  5. Borg-20

    Time frame: Day 1

    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.

  6. Borg-20

    Time frame: Day 2

    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.

  7. Pain Numerical Rating Scale (NRS)

    Time frame: Day 1

    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.

  8. Pain Numerical Rating Scale (NRS)

    Time frame: Day 2

    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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation on Brain Connectivity and Pain Sensitivity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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