Non-inflammatory Neuropathic PainLOGIN_NGFNCT02159170
Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor
A study testing NGF injection in people with Non-inflammatory Neuropathic Pain and Healthy Subjects, run by Prof Herta Flor at 1 site in Germany.
Trial summary
Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-inflammatory Neuropathic Pain, Healthy Subjects
- What is being tested?
- NGF injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Dec 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no acute or chronic disease
- no acute or chronic pain
- age: 18-60 years
- male
- no medication use
Who cannot join
- metallic parts in the body
- claustrophobia
- drug or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Representation of NGF-induced Hyperalgesia
Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. The investigators plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.
- Being tested
- NGF injection
- Keywords
- Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGF injectionBiological
single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm
| Study group | Role | What they receive |
|---|---|---|
| NGF | Experimental | injection of 50 µl NGF, once into the left volar forearm and injection of 50 µl NaCl (sodium chloride) once into the right volar forearm Receives: Biological: NGF injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in activation of the pain processing and resting state networks
Activation of the resting state network (using functional magnetic resonance imaging (fMRI) and a standard echo planar imaging (EPI) sequence) as well as acitvation of the pain processing network (using fMRI and a standard EPI sequence) in response to painful stimulation, will be measured before and after injection of NGF into the volar forearm of the participant.
Particants are measured 0-4 days before injection (baseline) and then again 4-7 days after injection (to measure changes due to NGF injection).
Measured: baseline to one week
Secondary outcomes (1)
Changes in pain intensity, unpleasentness and suffering ratings
Pain will be applied by using impact stimulation to the side where NGF was injected as well as a control side. Pain and tolerance thresholds as well as 3 ratings of intensity/unpleasantness and suffering will be obtained immediately after stimulation.
This will take place before NGF injection (baseline, 0-4 days) and after NGF injection (4-7 days).
Ratings will be conducted on visual analog scale from 0 (no pain/unpleasantess/suffering) to 100 (worst pain/unpleasantness/suffering imaginable).
Measured: baseline to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Neuropathic PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Herta Flor
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor-investigator, Prof Herta Flor, Central Institute of Mental Health, Mannheim
- Investigators
- Herta Flor, PhD, Principal investigator, Medical Faculty Mannheim, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159170
- Sponsor's protocol ID
- LOGIN_NGF
- Other IDs
- 01ED1010D
- Acronym
- LOGIN_NGF
- Status last verified
- Jan 2015
- First submitted
- 3 Jun 2014
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Representation of NGF-induced Hyperalgesia
- ClinicalTrials.gov ID
- NCT02159170
- Acronym / sponsor ID
- LOGIN_NGF / LOGIN_NGF
- Keywords
- Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prof Herta FlorUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Jun 2014 (estimated)
- 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.
Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. The investigators plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGF | Experimental | Biological: NGF injectioninjection of 50 µl NGF, once into the left volar forearm and injection of 50 µl NaCl (sodium chloride) once into the right volar forearm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- no acute or chronic disease
- no acute or chronic pain
- age: 18-60 years
- male
- no medication use
Key exclusion criteria (3 listed)
- metallic parts in the body
- claustrophobia
- drug or substance abuse
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 |
|---|---|---|
| NGF injectionsingle injection of NGF into the volar forearm / single injection of NaCl into the volar forearm | Biological | NGF |
Primary outcome
Changes in activation of the pain processing and resting state networks
Time frame: baseline to one week
Activation of the resting state network (using functional magnetic resonance imaging (fMRI) and a standard echo planar imaging (EPI) sequence) as well as acitvation of the pain processing network (using fMRI and a standard EPI sequence) in response to painful stimulation, will be measured before and after injection of NGF into the volar forearm of the participant. Particants are measured 0-4 days before injection (baseline) and then again 4-7 days after injection (to measure changes due to NGF injection).
1 secondary outcome
Changes in pain intensity, unpleasentness and suffering ratings
Time frame: baseline to one week
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 16 Jan 2015.
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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.
Herta Flor, PhD principal investigator
Medical Faculty Mannheim, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGF injection in people with Non-inflammatory Neuropathic Pain and Healthy Subjects, run by Prof Herta Flor at 1 site in Germany.
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 5 inclusion and 3 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 16 Jan 2015. 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 Germany. 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?
Changes in activation of the pain processing and resting state networks (time frame: baseline to one week). 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 16 Jan 2015.