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Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07058584
Enrollment
20
Registered
2025-07-10
Start date
2025-04-01
Completion date
2026-05-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerobic Exercise, Repetitive Transcranial Magnetic Stimulation (rTMS)

Brief 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. 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.

Interventions

DEVICErepetitive Transcranial Magnetic Stimulation

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.

DEVICESham repetitive Transcranial Magnetic Stimulation

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.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Randomization is applied only at the participant level: each participant is randomly assigned to start with either the active or sham condition, with the alternate condition administered in the second session. The study is single-blinded, meaning that participants are blinded to the intervention type (active vs. sham), while the investigators administering the sessions are aware of the allocation.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cortical connectivityDay 1Global and local mean field amplitude

Secondary

MeasureTime frameDescription
Pain Pressure ThresholdDay 1Pain Pressure Threshold in kPa will be measured 3 times per session using handheld algometer.
Cortical excitabilityDay 1TMS-evoked potentials from the TMS-EEG.
Borg-20Day 1Questionnaire 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.
Pain Numerical Rating Scale (NRS)Day 1The 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.

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATOREnrico De Martino, MD, PhD

Aalborg University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026