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Assessment of Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02138344
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
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.

Condition or disease
Spinal Cord Injury + Peripheral Nerve Diseases

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : April 2006
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

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Groups and Cohorts
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Group/Cohort
SCI subjects
Chronic and traumatic SCI subjects
Healthy control subjects
Subjects with peripheral nerve diseases


Outcome Measures
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Primary Outcome Measures :
  1. Pain, sensory and autonomic assessments [ Time Frame: 2 - 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with SCI and peripheral nerve diseases
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138344


Contacts
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Contact: Michèle Hubli +41 44 510 72 03 michele.hubli@balgrist.ch

Locations
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Switzerland
Curt, Armin, MD Recruiting
Zurich, Switzerland, 8008
Sponsors and Collaborators
University of Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02138344    
Other Study ID Numbers: EK-04/2006 / PB_2016-02051
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Spinal Cord Injuries
Nervous System Diseases
Peripheral Nervous System Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neuromuscular Diseases