Spinal Cord Injury + Peripheral Nerve DiseasesNCT02138344
Assessment of Neuropathic Pain
An observational study of Spinal Cord Injury + Peripheral Nerve Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury + Peripheral Nerve Diseases
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2006to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with SCI and peripheral nerve diseases
Who may be able to join
- Uninjured
- Scord injured subjects
- Subjects with peripheral nerve diseases
- Patients resident in Switzerland
Who cannot join
- Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent)
- For fMRI measurements: "yes" for any item in the MR-risk questionnaire
- Patients resident outside from Switzerland
Trial locations and contacts
1 site in 1 country.
About this study
Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.
- Medical subject headings
- Spinal Cord Injuries, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCI subjects | Chronic and traumatic SCI subjects | |
| Healthy control subjects | Not described | |
| Subjects with peripheral nerve diseases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, sensory and autonomic assessments
Measured: 2 - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start1 Apr 2006
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury + Peripheral Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138344
- Sponsor's protocol ID
- EK-04/2006 / PB_2016-02051
- Status last verified
- Jan 2025
- First submitted
- 12 May 2014
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gozzi N, Preatoni G, Ciotti F, Hubli M, Schweinhardt P, Curt A, Raspopovic S. Unraveling the physiological and psychosocial signatures of pain by machine learning. Med. 2024 Dec 13;5(12):1495-1509.e5. doi: 10.1016/j.medj.2024.07.016. Epub 2024 Aug 7.
PubMed 39116869
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02138344
- Acronym / sponsor ID
- EK-04/2006 / PB_2016-02051
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCI subjects | – | –Chronic and traumatic SCI subjects |
| Healthy control subjects | – | – |
| Subjects with peripheral nerve diseases | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with SCI and peripheral nerve diseases
Key inclusion criteria (4 listed)
- Uninjured
- Scord injured subjects
- Subjects with peripheral nerve diseases
- Patients resident in Switzerland
Key exclusion criteria (3 listed)
- Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent)
- For fMRI measurements: "yes" for any item in the MR-risk questionnaire
- Patients resident outside from Switzerland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain, sensory and autonomic assessments
Time frame: 2 - 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 39116869Gozzi N, Preatoni G, Ciotti F, Hubli M, Schweinhardt P, Curt A, Raspopovic S. Unraveling the physiological and psychosocial signatures of pain by machine learning. Med. 2024 Dec 13;5(12):1495-1509.e5. doi: 10.1016/j.medj.2024.07.016. Epub 2024 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury + Peripheral Nerve Diseases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, sensory and autonomic assessments (time frame: 2 - 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.