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Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354624
Enrollment
24
Registered
2017-11-28
Start date
2017-11-26
Completion date
2018-02-28
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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);

Interventions

DRUGSterile solutions of recombinant human nerve growth factor (NGF)

The intramuscular injections of NGF cause muscle soreness.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain ratingChange from baseline at 2 weeksPain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)

Secondary

MeasureTime frameDescription
Muscle sorenessChange from baseline at 2 weeks7-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'
Patient-rated Tennis Elbow EvaluationChange from baseline at 2 weeksThe Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Alpha oscillationsChange from baseline at 1 weeksContinuous EEG recording
Motor evoked potentialsChange from baseline at 1 weekTranscranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle
Sensory evoked potentialsChange from baseline at 1 weekEEG recodring
Pressure pain thresholdsChange from baseline at 2 weeksPressure applied to the surface of the skin using a handheld algometer.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026