Menu
Recruiting NCT06443281

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

— Observational Spinal Cord Injuries Pain, Neuropathic Nociceptive Pain Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurophysiology, Cardiovascular test, Experimental pain paradigms, Quantitative sensory testing.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Pain, Neuropathic, Nociceptive Pain, Neuropathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Neurophysiology
    Pain-related evoked potentials and nerve conduction studies
  • Diagnostic test Cardiovascular test
    Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
  • Diagnostic test Experimental pain paradigms
    Temporal summation of pain, conditioned pain modulation, offset analgesia
  • Diagnostic test Quantitative sensory testing
    Thermal and mechanical sensory testing
  • Diagnostic test Clinical pain phenotype
    Pain drawings, plus and minus signs of pain
  • Diagnostic test Pupillometry
    Pupil size changes after phasic and tonic sensory stimulation

Primary outcome measures

  • Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity [Time frame: Longitudinal: change from 1 month up to 12 months]
  • 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)]
  • 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)]
Secondary outcome measures (12)
  • Spinal cord injury patients / healthy controls: somato-sensory evoked potentials [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: somato-sensory evoked potentials [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: contact-heat evoked potentials [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: contact-heat evoked potentials [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: N13 spinal potential [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: N13 spinal potential [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: motor neurographies [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Time frame: Longitudinal: change from 1 month up to 12 months]
  • Spinal cord injury patients / healthy controls: sensory neurography [Time frame: Longitudinal: change from 1 month up to 12 months]

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
  • Control cohorts with peripheral neuropathy:
  • General inclusion criteria:
  • Aged between 18-80 years
  • Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
  • Peripheral neuropathy with or without neuropathic pain
  • Additional inclusion criteria for longitudinal study:
  • Peripheral neuropathy since less than one month
  • Additional inclusion criteria for cross-sectional study:
  • Peripheral neuropathy since more than one year
  • Control cohorts without neuropathy / healthy volunteers
  • General inclusion criteria:
  • Aged between 18-80 years
  • No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Balgrist University Hospital — Zurich

Identifiers

NCT: NCT06443281 · 2024-00134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗