Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury (NCT06443281) | Clinical Trial Compass
RecruitingNot Applicable
Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
Switzerland300 participantsStarted 2024-04-17
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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)
3
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)