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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

Tracking Information
First Submitted Date May 12, 2014
First Posted Date May 14, 2014
Last Update Posted Date July 16, 2020
Study Start Date April 2006
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2016)
Pain, sensory and autonomic assessments [ Time Frame: 2 - 4 weeks ]
Original Primary Outcome Measures
 (submitted: May 12, 2014)
Pain and Sensory Assessment [ Time Frame: 2 - 4 weeks ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Neuropathic Pain
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects with SCI and peripheral nerve diseases
Condition Spinal Cord Injury + Peripheral Nerve Diseases
Intervention Not Provided
Study Groups/Cohorts
  • SCI subjects
    Chronic and traumatic SCI subjects
  • Healthy control subjects
  • Subjects with peripheral nerve diseases
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 27, 2016)
300
Original Estimated Enrollment
 (submitted: May 12, 2014)
100
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Michèle Hubli +41 44 510 72 03 michele.hubli@balgrist.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02138344
Other Study ID Numbers EK-04/2006 / PB_2016-02051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Zurich
Verification Date July 2020