Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation

NCT07058584 | Active Not Recruiting DMC

• 1 other identifier: N-20240053 - Study 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Cortical connectivity

  Global and local mean field amplitude

  Day 1

• Cortical connectivity

  Global and local mean field amplitude

  Day 2

Secondary Outcomes (8)

• Pain Pressure Threshold

  Day 1

• Pain Pressure Threshold

  Day 2

• Cortical excitability

  Day 1

• Cortical excitability

  Day 2

• Borg-20

  Day 1

Study Arms (1)

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

Device: repetitive Transcranial Magnetic Stimulation; Device: Sham repetitive Transcranial Magnetic Stimulation

Interventions

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.

Aerobic Exercise & rTMS

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.

Aerobic Exercise & rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Enrico De Martino, MD, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

DK (1)