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Completed

NCT Number: NCT05689606

Cortical Excitability, Cognitive Functions, and Peripheral Signaling Molecules

It is widely known that exercise creates structural and functional changes in the brain. Synaptic plasticity develops through exercise, thus improving brain functions. It is suggested that skeletal muscle contraction and peripheral signal molecules secreted from various tissues, especially skeletal muscle, contribute to exercise's effect on the brain's structure and function. These signals synthesized and released from skeletal muscle are called myokines. Brain-derived neurotrophic factor (BDNF) and Cathepsin B are two of these myokines, which have been reported to cross the blood-brain barrier following secretion in the periphery and affect the structure and functions of the brain. Transcranial magnetic stimulation (TMS) allows to evaluate the synaptic plasticity responses of the motor cortex to exercise, while cognitive function responses are evaluated via cognitive tests. Additionally, exercise type and intensity influence the responses of cortical excitability and cognitive function. This research proposal aims to investigate how acute high-intensity intermittent exercise (HIIT) changes primary motor cortex (M1) excitability, M1-related cognitive functions, and peripheral BDNF and Cathepsin B levels in healthy sedentary adults and to investigate the relationship between these neurophysiological parameters. All parameters will be measured before and after the acute exercise. M1 excitability will be evaluated through resting motor threshold, short interval intracortical inhibition, and input-output curve measurements. Cognitive functions will be evaluated through mental rotation and working memory tasks, and peripheral signal responses will be measured by serum levels of BDNF and Cathepsin B. Our hypotheses are: 1) Acute HIIT will increase peripheral BDNF and CTSB level, cortical excitability, and M1-specific cognitive function performance. 2) M1 excitability, cognitive function performance, and peripheral BDNF and CTSB increase will be related following exercise. Our findings will have the potential to be a guide for the integration of exercise into daily life and will provide cortical and peripheral data on the neurophysiological basis of the relationship between exercise and cognition.

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Key information

Conditions

Healthy

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Turkey (Türkiye)

About this study

Participants Twenty-eight healthy young adults (female|male:14|14) aged 20-30 years will have participated in the study.

Participants will be at least undergraduate students, right-handed dominant, exercising <150 minutes per week in the last six months. Before the experiment, the participants will be evaluated for their background, family history, and whether they have any health complaints that prevent them from exercising.

With the adult transcranial magnetic stimulation safety screening questionnaire, participants in the risk group for brain stimulation, those with intracranial implants and contraindications, and those with a history of any psychiatric or neurological disease, seizures, any serious medical condition, or pregnancy will be excluded. The hand preference questionnaire will evaluate hand preference, and physical activity status will be evaluated by the short version of the international physical activity questionnaire. The cardiorespiratory fitness will be assessed with the graded maximal exercise stress test. The N-back test is a continuous performance test used to assess working memory capacity. The mental rotation test will evaluate the mental rotation score. The research team designed both tests.

Transcranial magnetic stimulation will be used to assess corticomotor excitability. Resting Motor Threshold (RMT), Short Interval Intracortical Inhibition (SICI), and input-output curve measurements will be performed on all participants in our study for the TMS study.

BDNF and CTSB measurements of the participants will be made both at baseline and following the acute exercise.

HIIT exercise lasting 23 minutes will be performed on the bicycle ergometer. Participants will make 3 visits to the laboratory. First session: Cardiorespiratory fitness assessment, all questionnaires. Second session: TMS analyses, cognitive assessments, HIIT, myokine assessments Third session: TMS analyses, cognitive assessments, control (watching a nature documentary).

The second and third sessions will be performed by cross-over design. Data analysis will be performed with two-way repeated ANOVA to determine the effect of within-group factors (control and HIIT) and time (PRE and POST) on corticospinal excitability and other parameters. When the effect size was calculated as ɳp2 >0.26, the sample size was calculated a priori as n = 22. Considering possible data losses, the number of participants was determined as 28.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being right-handed
  • Aged between 20 and 30 years
  • Being sedentary

Exclusion criteria

  • having intracranial implants
  • history of psychiatric or neurological disease, seizure, any serious medical condition or pregnancy

Treatment and study plan

Exercise

Behavioral

Exercise includes acute high-intensity interval training.

Primary outcomes

  1. Resting motor threshold

    Time frame: Change from Baseline resting motor threshold immediately following acute exercise

    The amount of transcranial magnetic stimulation machine output necessary to produce a motor-evoked potential that exceeds a defined peak-to-peak amplitude. Lower scores mean a better outcome.

  2. Short interval intracortical inhibition

    Time frame: Change from Baseline short interval intracortical inhibition immediately following acute exercise

    The relative amplitude reduction of motor evoked potentials by subthreshold conditioning stimuli.

  3. Input output curve

    Time frame: Change from Baseline input output curve immediately following acute exercise

    The input-output curve is a sigmoid-shaped relation between the MEP amplitude at incremented TMS intensities. Higher scores mean a better outcome.

  4. Working memory

    Time frame: Change from Baseline working memory score immediately following acute exercise

    The small amount of information that can be held in mind and used in the execution of cognitive tasks. Higher scores mean a better outcome.

  5. Serum BDNF

    Time frame: Change from Baseline serum BDNF immediately following acute exercise

    Serum level of BDNF. Higher scores mean a better outcome.

  6. Mental rotation

    Time frame: Change from Baseline mental rotation score immediately following acute exercise

    The ability to transform a mental representation of an object so as to accurately predict how the object would look from a different angle. Higher scores mean a better outcome.

  7. Serum Cathepsin B

    Time frame: Change from Baseline serum Cathepsin B immediately following acute exercise

    Serum level of Cathepsin B. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Gazi University

Registry information

Official study title

The Relationship of Cortical Excitability, Cognitive Functions, and Peripheral Signaling Molecules Following Acute Exercise

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Aug 5, 2024

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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