- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138344
Assessment of Neuropathic Pain
August 24, 2023 updated by: University of Zurich
Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases.
The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin.
Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michèle Hubli
- Phone Number: +41 44 510 72 03
- Email: michele.hubli@balgrist.ch
Study Locations
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Zurich, Switzerland, 8008
- Recruiting
- Curt, Armin, MD
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Subjects with SCI and peripheral nerve diseases
Description
Inclusion Criteria:
- Uninjured
- Scord injured subjects
- Subjects with peripheral nerve diseases
Exclusion Criteria:
- Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent)
- For fMRI measurements: "yes" for any item in the MR-risk questionnaire
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
Cohorts and Interventions
Group / Cohort |
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Healthy control subjects
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SCI subjects
Chronic and traumatic SCI subjects
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Subjects with peripheral nerve diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain, sensory and autonomic assessments
Time Frame: 2 - 4 weeks
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2 - 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2006
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 12, 2014
First Submitted That Met QC Criteria
May 12, 2014
First Posted (Estimated)
May 14, 2014
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-04/2006 / PB_2016-02051
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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