Peripheral Nerve InjuriesNCT03082820
Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries
An observational study of Peripheral Nerve Injuries, run by Ruhr University of Bochum.
Trial summary
The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and Nerve conduction studies (NCS)
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2015to 5 Nov 2016
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.
Who may be able to join
- Peripheral Nerve Injury
Who cannot join
- Polyneuropathy
- Contralateral peripheral nerve injury
- Severe psychiatric disorders
- Disorders affecting central nervous system
About this study
Official title: Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain
The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST), Nerve conduction studies (NCS)
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain-related evoked potentials (PREP)Diagnostic test
PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
Quantitative Sensory Testing (QST)Diagnostic test
QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.
Nerve conduction studies (NCS)Diagnostic test
NCS were performed with patients only.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and nerve conduction studies (NCS) were performed with patients with peripheral nerve injury. Receives: Diagnostic Test: Pain-related evoked potentials (PREP); Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Nerve conduction studies (NCS) | |
| Controls | Pain-related evoked potentials (PREP) and Quantitative Sensory Testing (QST) were performed with healthy adults. Receives: Diagnostic Test: Pain-related evoked potentials (PREP); Diagnostic Test: Quantitative Sensory Testing (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
N1-latency
N1-latency of pain-related evoked potentials in ms
Measured: 1 day
Secondary outcomes (1)
N1P1-amplitude
Amplitude of pain-related evoked potentials in µV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Feb 2015
- Primary completion5 Nov 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr. med., Study director, University Hospital Bergmannsheil Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082820
- Sponsor's protocol ID
- PREP2015
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03082820
- Acronym / sponsor ID
- PREP2015
- Conditions
- Peripheral Nerve Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 3 Feb 2015
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 17 Mar 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 study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Pain-related evoked potentials (PREP), Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Nerve conduction studies (NCS)Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and nerve conduction studies (NCS) were performed with patients with peripheral nerve injury. |
| Controls | – | Diagnostic Test: Pain-related evoked potentials (PREP), Diagnostic Test: Quantitative Sensory Testing (QST)Pain-related evoked potentials (PREP) and Quantitative Sensory Testing (QST) were performed with healthy adults. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.
Key inclusion criteria (1 listed)
- Peripheral Nerve Injury
Key exclusion criteria (4 listed)
- Polyneuropathy
- Contralateral peripheral nerve injury
- Severe psychiatric disorders
- Disorders affecting central nervous system
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 |
|---|---|---|
| Pain-related evoked potentials (PREP)PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold. | Diagnostic test | Controls, Patients |
| Quantitative Sensory Testing (QST)QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain. | Diagnostic test | Controls, Patients |
| Nerve conduction studies (NCS)NCS were performed with patients only. | Diagnostic test | Patients |
Primary outcome
N1-latency
Time frame: 1 day
N1-latency of pain-related evoked potentials in ms
1 secondary outcome
N1P1-amplitude
Time frame: 1 day
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 21 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Christoph Maier, Prof. Dr. med. study director
University Hospital Bergmannsheil Bochum
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Ruhr University of Bochum.
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 1 inclusion and 4 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
N1-latency (time frame: 1 day). 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 21 Mar 2017.