Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

NCT ID: NCT06443281

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-17

Study Completion Date

2030-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries Pain, Neuropathic Nociceptive Pain Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with spinal cord injury with neuropathic pain

Neurophysiology

Intervention Type DIAGNOSTIC_TEST

Pain-related evoked potentials and nerve conduction studies

Cardiovascular test

Intervention Type DIAGNOSTIC_TEST

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

Experimental pain paradigms

Intervention Type DIAGNOSTIC_TEST

Temporal summation of pain, conditioned pain modulation

Quantitative sensory testing

Intervention Type DIAGNOSTIC_TEST

Thermal and mechanical sensory testing

Clinical pain phenotype

Intervention Type DIAGNOSTIC_TEST

Pain drawings, plus and minus signs of pain

Patients with spinal cord injury but without neuropathic pain

Neurophysiology

Intervention Type DIAGNOSTIC_TEST

Pain-related evoked potentials and nerve conduction studies

Cardiovascular test

Intervention Type DIAGNOSTIC_TEST

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

Experimental pain paradigms

Intervention Type DIAGNOSTIC_TEST

Temporal summation of pain, conditioned pain modulation

Quantitative sensory testing

Intervention Type DIAGNOSTIC_TEST

Thermal and mechanical sensory testing

Patients with peripheral neuropathy

Neurophysiology

Intervention Type DIAGNOSTIC_TEST

Pain-related evoked potentials and nerve conduction studies

Cardiovascular test

Intervention Type DIAGNOSTIC_TEST

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

Experimental pain paradigms

Intervention Type DIAGNOSTIC_TEST

Temporal summation of pain, conditioned pain modulation

Quantitative sensory testing

Intervention Type DIAGNOSTIC_TEST

Thermal and mechanical sensory testing

Clinical pain phenotype

Intervention Type DIAGNOSTIC_TEST

Pain drawings, plus and minus signs of pain

Healthy subjects

Neurophysiology

Intervention Type DIAGNOSTIC_TEST

Pain-related evoked potentials and nerve conduction studies

Cardiovascular test

Intervention Type DIAGNOSTIC_TEST

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

Experimental pain paradigms

Intervention Type DIAGNOSTIC_TEST

Temporal summation of pain, conditioned pain modulation

Quantitative sensory testing

Intervention Type DIAGNOSTIC_TEST

Thermal and mechanical sensory testing

Interventions

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Neurophysiology

Pain-related evoked potentials and nerve conduction studies

Intervention Type DIAGNOSTIC_TEST

Cardiovascular test

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

Intervention Type DIAGNOSTIC_TEST

Experimental pain paradigms

Temporal summation of pain, conditioned pain modulation

Intervention Type DIAGNOSTIC_TEST

Quantitative sensory testing

Thermal and mechanical sensory testing

Intervention Type DIAGNOSTIC_TEST

Clinical pain phenotype

Pain drawings, plus and minus signs of pain

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
* 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
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Freund, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Michèle Hubli, PD Dr.

Role: CONTACT

+41 44 510 72 03

Facility Contacts

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Michèle Hubli, PD Dr.

Role: primary

+41 44 510 72 03

Other Identifiers

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2024-00134

Identifier Type: -

Identifier Source: org_study_id

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