ClinicalTrials.gg
CompletedNCT03354624Updated Mar 5, 2018

Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

An interventional study of Sterile solutions of recombinant human nerve growth factor (NGF) in Nerve Growth Factor, Exercise and Motor Activity, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Primary conditionHyperalgesiaRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hyperalgesia
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Hyperalgesia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Hyperalgesia with a site in Denmark — none open to participants now, none under way, none of them phase 3. Hyperalgesia · Denmark.

Enrollment
7th of 15
24 · median 23
Started
2017
with 2 others
No phase
6 of 17
none open now
Registered
15th of 17
by date
Lead sponsor
4 of 17
Aalborg University

Among the 17 studies in Hyperalgesia with a site in Denmark, this one is the 7th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 with no phase, and was the 15th registered.

Hyperalgesia

166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.

Browse Hyperalgesia studies →

Open to participants now

None of the 17 studies in Hyperalgesia with a site in Denmark is open now.

Who these studies take

Of the 8 Hyperalgesia studies recruiting now, 4 (50%) set no upper age limit and 2 (25%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 17 studies in Hyperalgesia with a site in Denmark as a file.
02

Study 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).

Read the 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);

03

Conditions studied

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

Browse trials for

04

In context

Hyperalgesia Reclassified

166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 142 interventional studies indexed under Hyperalgesia.

Browse Hyperalgesia studies →

Lead sponsor

Aalborg University is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Compared within Hyperalgesia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Sterile solutions of recombinant human nerve growth factor (NGF)

  • Experimental
    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.

    Drug: Sterile solutions of recombinant human nerve growth factor (NGF)

Interventions

07

What researchers measure

Primary outcomes

  1. Pain rating

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

    Time frame: Change from baseline at 2 weeks

Secondary outcomes

  1. Muscle soreness

    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'

    Time frame: Change from baseline at 2 weeks

  2. Patient-rated Tennis Elbow Evaluation

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

    Time frame: Change from baseline at 2 weeks

  3. Pressure pain thresholds

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

    Time frame: Change from baseline at 2 weeks

  4. Motor evoked potentials

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

    Time frame: Change from baseline at 1 week

  5. Sensory evoked potentials

    EEG recodring

    Time frame: Change from baseline at 1 week

  6. Alpha oscillations

    Continuous EEG recording

    Time frame: Change from baseline at 1 weeks

08

Study locations

1 site
  • Aalborg University
    Aalborg, Nordjylland 9000, Denmark
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Feb 2018, 3 months.

Of 27 non-industry interventional studies with no phase under Hyperalgesia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's 3 months is below that.

Counting every sponsor, half of 27 studies reached it within 11 months; a quarter within 4 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2017
First posted
Nov 28, 2017
StartActual
Nov 26, 2017
Primary completionActual
Feb 28, 2018
CompletionActual
Feb 28, 2018
Last update
Mar 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03354624
Lead sponsor
Aalborg University
Responsible party
Enrico De Martino (Medical Doctor, Aalborg University) — Principal investigator
First posted
Nov 28, 2017
Start date
Nov 26, 2017
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018
Last update
Mar 5, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Nerve Growth Factor

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