- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06084455
TMS-evoked Potentials During Aerobic Exercise (TMS-EEGxercise)
The Effect of Aerobic Exercise on Brain Connectivity
Study Overview
Status
Intervention / Treatment
Detailed Description
Chronic musculoskeletal pain disorders rank second only to mental and behavioural disorders as a major contributor to worldwide years lived with disability. Chronic musculoskeletal pain restricts mobility, decreases cardiorespiratory capacity and musculoskeletal function, and ultimately reduces exercise capacity and quality of life. Thus, there is an urgent need for new, effective, and affordable strategies to address this growing problem, particularly in health systems around the world.
Abnormal brain connectivity patterns disrupt normal brain function in a specific neural network, causing brain circuit malfunctions and resulting in symptoms such as chronic pain. The advent of electroencephalography (EEG) compatible with transcranial magnetic stimulation (TMS-EEG) has allowed the measurement of the cortical excitability and connectivity of a single pulse of TMS in any scalp region, providing insights into cortical excitability and connectivity that were not previously possible with techniques exclusively based on MEP, create a map of activation caused by a localized pulse of stimulation. Furthermore, TMS-EEG allows recording the spread and the characteristics of the perturbations caused by a single TMS pulse across the cortex (recorded by several electrodes from an EEG cap). Physical exercise has been shown to have a positive impact on brain functioning. Regular exercise promotes the growth of new brain cells and improves the survival of existing ones. Studies have shown that regular exercise improves cognitive function, memory, and mood, and exercise has been linked to increased production of neurotransmitters, hormones, and growth factors that promote brain health. However, to date, no studies have investigated the effect of aerobic exercise on brain excitability and connectivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nordjylland
-
Gistrup, Nordjylland, Denmark, 9260
- Aalborg University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy men and women
- Speak and understand English
Exclusion Criteria:
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise
30 minutes of aerobic exercise will be performed by the participants before and after cortical connectivity measurements.
|
30 minutes of aerobic exercise on a stationary bike
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical connectivity
Time Frame: Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)
|
Global and local mean field amplitude
|
Cortical connectivity changes will be investigated before and after 30-min aerobic exercise (1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical excitability
Time Frame: Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
|
TMS-evoked potentials
|
Cortical excitability changes will be investigated before and after 30-min aerobic exercise (1 hour)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N-20210047-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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