Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries

March 17, 2017 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.

Description

Inclusion Criteria:

  • Peripheral Nerve Injury

Exclusion Criteria:

  • Polyneuropathy
  • Contralateral peripheral nerve injury
  • Severe psychiatric disorders
  • Disorders affecting central nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Pain-related evoked potentials (PREP), Quantitative Sensory Testing (QST) and nerve conduction studies (NCS) were performed with patients with peripheral nerve injury.
Diagnostic test: Pain-related evoked potentials (PREP)
PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
Diagnostic test: Quantitative Sensory Testing (QST)
QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.
Diagnostic test: Nerve conduction studies (NCS)
NCS were performed with patients only.
Controls
Pain-related evoked potentials (PREP) and Quantitative Sensory Testing (QST) were performed with healthy adults.
Diagnostic test: Pain-related evoked potentials (PREP)
PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
Diagnostic test: Quantitative Sensory Testing (QST)
QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N1-latency
Time Frame: 1 day
N1-latency of pain-related evoked potentials in ms
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N1P1-amplitude
Time Frame: 1 day
Amplitude of pain-related evoked potentials in µV
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Study Director: Christoph Maier, Prof. Dr. med., University Hospital Bergmannsheil Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 3, 2015

Primary Completion (Actual)

November 5, 2016

Study Completion (Actual)

November 5, 2016

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 12, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREP2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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