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Completed

NCT Number: NCT03354624

Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

The purpose of this study is to investigate the sensory-motor cortical excitability response to delayed onset muscle soreness (DOMS) on Extensor Carpi Radialis (ECR) muscle during muscle hyperalgesia provoked by nerve growth factor (NGF).

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Key information

Conditions

Nerve Growth Factor Abnormality of SSEPs Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Exercise Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Hyperalgesia Motor Activity Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, North Denmark, 9000, Denmark

About this study

The purpose of this study is to assess changes in sensory-motor cortical excitability during experimental muscle hyperalgesia across several days provoked by injections of nerve growth factor (NGF) into the Extensor Carpi Radialis (ECR) muscle and delayed onset muscle soreness (DOMS) of the ECR muscle.

It was hypothesized that muscle hyperalgesia across several days would result in:

i) Increased sensory cortical excitability, based on somatosensory evoked potentials by means of electrical stimulation of the radial nerve, (increase of central-parietal evoked-potential P45 and decrease of frontal evoked-potential N30); ii) Increased corticomotor excitability of a ECR (increase map volume and number of active sites), assessed as motor evoked potentials induced by transcranial magnetic stimulation in primary motor cortex (M1); iii) Reduction of alpha oscillation based on nociceptive stimulus-evoked suppression of alpha activity in sensory regions (recording electrodes on contra-lateral parietal area);

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women
  • Speak and understand English.

Exclusion criteria

Pregnancy

  • 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
  • Previous experience with rTMS
  • 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)

Treatment and study plan

Sterile solutions of recombinant human nerve growth factor (NGF)

Drug

The intramuscular injections of NGF cause muscle soreness.

Primary outcomes

  1. Pain rating

    Time frame: Change from baseline at 2 weeks

    Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)

Secondary outcomes

  1. Muscle soreness

    Time frame: Change from baseline at 2 weeks

    7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'

  2. Patient-rated Tennis Elbow Evaluation

    Time frame: Change from baseline at 2 weeks

    The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm

  3. Pressure pain thresholds

    Time frame: Change from baseline at 2 weeks

    Pressure applied to the surface of the skin using a handheld algometer.

  4. Motor evoked potentials

    Time frame: Change from baseline at 1 week

    Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle

  5. Sensory evoked potentials

    Time frame: Change from baseline at 1 week

    EEG recodring

  6. Alpha oscillations

    Time frame: Change from baseline at 1 weeks

    Continuous EEG recording

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2017
Registry last updated
Mar 5, 2018

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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