Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries
Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain
1 other identifier
observational
64
0 countries
N/A
Brief 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. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2016
CompletedFirst Submitted
Initial submission to the registry
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 17, 2017
CompletedMarch 21, 2017
March 1, 2017
1.8 years
March 6, 2017
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
N1-latency
N1-latency of pain-related evoked potentials in ms
1 day
Secondary Outcomes (1)
N1P1-amplitude
1 day
Study Arms (2)
Patients
Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and nerve conduction studies (NCS) were performed with patients with peripheral nerve injury.
Controls
Pain-related evoked potentials (PREP) and Quantitative Sensory Testing (QST) were performed with healthy adults.
Interventions
PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.
Eligibility Criteria
Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.
You may qualify if:
- Peripheral Nerve Injury
You may not qualify if:
- Polyneuropathy
- Contralateral peripheral nerve injury
- Severe psychiatric disorders
- Disorders affecting central nervous system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Maier, Prof. Dr. med.
University Hospital Bergmannsheil Bochum
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 17, 2017
Study Start
February 3, 2015
Primary Completion
November 5, 2016
Study Completion
November 5, 2016
Last Updated
March 21, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share