Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

NCT ID: NCT03354624

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-26
• Study Completion Date: 2018-02-28

Brief Summary

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).

Detailed Description

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);

Conditions

Nerve Growth Factor; Exercise; Motor Activity; Abnormality of SSEPs; Hyperalgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Nerve growth factor group

Three injections of sterile solutions of recombinant human nerve growth factor (NGF) will be performed in the right extensor carpi radialis muscle to induce muscle hyperalgesia.

Group Type: EXPERIMENTAL

Sterile solutions of recombinant human nerve growth factor (NGF)

Intervention Type: DRUG

The intramuscular injections of NGF cause muscle soreness.

Nerve growth factor group + delayed onset muscle soreness

Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.

Group Type: EXPERIMENTAL

Sterile solutions of recombinant human nerve growth factor (NGF)

Intervention Type: DRUG

The intramuscular injections of NGF cause muscle soreness.

Interventions

Sterile solutions of recombinant human nerve growth factor (NGF)

The intramuscular injections of NGF cause muscle soreness.

Intervention Type: DRUG

Eligibility Criteria

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
• 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)

• 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

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20160022

Identifier Type: -

Identifier Source: org_study_id