Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation

NCT ID: NCT07058584

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-31

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.

Conditions

Aerobic Exercise; Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic Exercise & rTMS

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

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type: 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

Intervention Type: 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.

Interventions

repetitive 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.

Intervention Type: DEVICE

Sham 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Enrico De Martino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico De Martino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Aalborg University

Gistrup, , Denmark

Countries

Denmark

Other Identifiers

N-20240053 - Study 2

Identifier Type: -

Identifier Source: org_study_id