Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

NCT06443281 | Recruiting

• 1 other identifier: 2024-00134
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Pain, Neuropathic; Nociceptive Pain; Neuropathy

Outcome Measures

Primary Outcomes (3)

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

  Pain drawings, plus and minus signs of pain

  Longitudinal: change from 1 month up to 12 months

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

  Pain drawings, plus and minus signs of pain

  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

  Pain drawings, plus and minus signs of pain

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

Secondary Outcomes (32)

• 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: 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

• Spinal cord injury patients / healthy controls: contact-heat evoked potentials

  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

Study Arms (4)

Patients with spinal cord injury with neuropathic pain

Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Clinical pain phenotype

Patients with spinal cord injury but without neuropathic pain

Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing

Patients with peripheral neuropathy

Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Clinical pain phenotype

Healthy subjects

Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing

Interventions

Neurophysiology DIAGNOSTIC_TEST

Pain-related evoked potentials and nerve conduction studies

Healthy subjects; Patients with peripheral neuropathy; Patients with spinal cord injury but without neuropathic pain; Patients with spinal cord injury with neuropathic pain

Cardiovascular test DIAGNOSTIC_TEST

Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability

Healthy subjects; Patients with peripheral neuropathy; Patients with spinal cord injury but without neuropathic pain; Patients with spinal cord injury with neuropathic pain

Experimental pain paradigms DIAGNOSTIC_TEST

Temporal summation of pain, conditioned pain modulation

Healthy subjects; Patients with peripheral neuropathy; Patients with spinal cord injury but without neuropathic pain; Patients with spinal cord injury with neuropathic pain

Quantitative sensory testing DIAGNOSTIC_TEST

Thermal and mechanical sensory testing

Healthy subjects; Patients with peripheral neuropathy; Patients with spinal cord injury but without neuropathic pain; Patients with spinal cord injury with neuropathic pain

Clinical pain phenotype DIAGNOSTIC_TEST

Pain drawings, plus and minus signs of pain

Patients with peripheral neuropathy; Patients with spinal cord injury with neuropathic pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In- and outpatients of Balgrist University Hospital Zurich

You may qualify if:

• Aged between 18-80 years
• Traumatic and non-traumatic etiology
• Para- and tetraplegic SCI
• Complete and incomplete SCI
• SCI with and without neuropathic pain
• SCI since less than one month
• SCI since more than one year
• Control cohorts with peripheral neuropathy:
• Aged between 18-80 years
• Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
• Peripheral neuropathy with or without neuropathic pain
• Peripheral neuropathy since less than one month
• Peripheral neuropathy since more than one year
• Control cohorts without neuropathy / healthy volunteers
• Aged between 18-80 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Nociceptive Pain

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Patrick Freund, Prof. Dr. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michèle Hubli, PD Dr.

CONTACT

+41 44 510 72 03; michele.hubli@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 5, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CH (1)