Clinical trial NCT06443281: Pain Phenotyping in Patients with Neuropathic Pain After Spinal Cord Injury
Official title: Pain Phenotyping in Patients with Neuropathic Pain After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Pain, Neuropathic
Nociceptive Pain
Neuropathy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2024-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In- and outpatients of Balgrist University Hospital Zurich

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.


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)

Primary outcomes:
measure: Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary outcomes:
measure: Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: contact-heat evoked potentials
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: contact-heat evoked potentials
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: N13 spinal potential
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: N13 spinal potential
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: motor neurographies
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: motor neurographies
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: motor neurographies
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: sensory neurography
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: sensory neurography
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: sensory neurography
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: resting blood pressure
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Patients with peripheral neuropathy / healthy controls: heart rate variability
timeFrame: Cross-sectional: once in a chronic stage (1 year post-injury)
measure: Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: conditioned pain modulation
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: conditioned pain modulation
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
measure: Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
timeFrame: Longitudinal: change from 1 month up to 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References: