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Clinical Trials/NCT06443281
NCT06443281
Recruiting
Not Applicable

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

University of Zurich1 site in 1 country300 target enrollmentApril 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Zurich
Enrollment
300
Locations
1
Primary Endpoint
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.

Registry
clinicaltrials.gov
Start Date
April 17, 2024
End Date
April 30, 2030
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Spinal injury cohort - general inclusion criteria:
  • Aged between 18-80 years
  • Traumatic and non-traumatic etiology
  • Para- and tetraplegic SCI
  • Complete and incomplete SCI
  • SCI with and without neuropathic pain
  • Additional inclusion criteria for longitudinal study:
  • SCI since less than one month
  • Additional inclusion criteria for cross-sectional study:
  • SCI since more than one year

Exclusion Criteria

  • Inability to follow study instructions
  • Pregnancy
  • Medically manifested psychological disorder
  • Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)

Outcomes

Primary Outcomes

Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity

Time Frame: Cross-sectional: once in a chronic stage (1 year post-injury)

Pain drawings, plus and minus signs of pain

Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity

Time Frame: Cross-sectional: once in a chronic stage (1 year post-injury)

Pain drawings, plus and minus signs of pain

Secondary Outcomes

  • Spinal cord injury patients / healthy controls: resting blood pressure(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Spinal cord injury patients / healthy controls: conditioned pain modulation(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: N13 spinal potential(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: somato-sensory evoked potentials(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: contact-heat evoked potentials(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Spinal cord injury patients / healthy controls: motor neurographies(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks(Longitudinal: change from 1 month up to 12 months)
  • Spinal cord injury patients / healthy controls: sensory neurography(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: heart rate variability(Cross-sectional: once in a chronic stage (1 year post-injury))
  • Patients with peripheral neuropathy / healthy controls: conditioned pain modulation(Longitudinal: change from 1 month up to 12 months)
  • Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks(Longitudinal: change from 1 month up to 12 months)

Study Sites (1)

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