Clinical trial NCT03354624: Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity
Official title: Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Growth Factor
Exercise
Motor Activity
Abnormality of SSEPs
Hyperalgesia
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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);

Eligibility criteria: 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)

Primary outcomes:
measure: Pain rating
timeFrame: Change from baseline at 2 weeks
Secondary outcomes:
measure: Muscle soreness
timeFrame: Change from baseline at 2 weeks
measure: Patient-rated Tennis Elbow Evaluation
timeFrame: Change from baseline at 2 weeks
measure: Pressure pain thresholds
timeFrame: Change from baseline at 2 weeks
measure: Motor evoked potentials
timeFrame: Change from baseline at 1 week
measure: Sensory evoked potentials
timeFrame: Change from baseline at 1 week
measure: Alpha oscillations
timeFrame: Change from baseline at 1 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
References: