Nerve Growth FactorNCT03354624
Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity
A study testing Sterile solutions of recombinant human nerve growth factor (NGF) in people with Nerve Growth Factor and Exercise, run by Aalborg University at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Growth Factor, Exercise, Motor Activity
- What is being tested?
- Sterile solutions of recombinant human nerve growth factor (NGF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Nov 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Speak and understand English.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation 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).
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:
- 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);
- Being tested
- Sterile solutions of recombinant human nerve growth factor (NGF)
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Motor Activity, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile solutions of recombinant human nerve growth factor (NGF)Drug
The intramuscular injections of NGF cause muscle soreness.
| Study group | Role | What they receive |
|---|---|---|
| Nerve growth factor group | Experimental | 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. Receives: Drug: Sterile solutions of recombinant human nerve growth factor (NGF) |
| Nerve growth factor group + delayed onset muscle soreness | Experimental | Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia. Receives: Drug: Sterile solutions of recombinant human nerve growth factor (NGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Measured: Change from baseline at 2 weeks
Secondary outcomes (6)
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'
Measured: Change from baseline at 2 weeks
Patient-rated Tennis Elbow Evaluation
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Measured: Change from baseline at 2 weeks
Pressure pain thresholds
Pressure applied to the surface of the skin using a handheld algometer.
Measured: Change from baseline at 2 weeks
Motor evoked potentials
Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle
Measured: Change from baseline at 1 week
Sensory evoked potentials
EEG recodring
Measured: Change from baseline at 1 week
Alpha oscillations
Continuous EEG recording
Measured: Change from baseline at 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start26 Nov 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Growth FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354624
- Sponsor's protocol ID
- N-20160022
- Status last verified
- Mar 2018
- First submitted
- 19 Nov 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity
- ClinicalTrials.gov ID
- NCT03354624
- Acronym / sponsor ID
- N-20160022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 26 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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);
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve growth factor group | Experimental | Drug: Sterile solutions of recombinant human nerve growth factor (NGF)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. |
| Nerve growth factor group + delayed onset muscle soreness | Experimental | Drug: Sterile solutions of recombinant human nerve growth factor (NGF)Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Speak and understand English.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile solutions of recombinant human nerve growth factor (NGF)The intramuscular injections of NGF cause muscle soreness. | Drug | Nerve growth factor group, Nerve growth factor group + delayed onset muscle soreness |
Primary outcome
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)
6 secondary outcomes
Muscle soreness
Time frame: Change from baseline at 2 weeks
Patient-rated Tennis Elbow Evaluation
Time frame: Change from baseline at 2 weeks
Pressure pain thresholds
Time frame: Change from baseline at 2 weeks
Motor evoked potentials
Time frame: Change from baseline at 1 week
Sensory evoked potentials
Time frame: Change from baseline at 1 week
Alpha oscillations
Time frame: Change from baseline at 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile solutions of recombinant human nerve growth factor (NGF) in people with Nerve Growth Factor and Exercise, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating (time frame: Change from baseline at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.