Central Post-stroke PainNCT05679297
Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders
An observational study of Central Post-stroke Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this observational study is to examine the association between exact lesion location and presence of thalamic CPSP (Central post-stroke pain) in a larger number of patients after thalamic stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Post-stroke Pain
- What is being tested?
- Quantitative sensory testing (QST), Magnetic resonance imaging (MRI) and Clinical interview/exam
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 May 2015to 27 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The recruitment of patients with thalamic pain will take place at the Department of Neurology, University Hospital Basel in collaboration with the chronic pain service of the Department of Anesthesiology, University Hospital Basel and the "Schmerzklinik Kirschgarten" in Basel. The recruitment of patients with thalamic stroke without pain as well as of patients with migraine (other pain disorder) will take place at the Department of Neurology, University Hospital Basel, the latter especially from the "Kopfsprechstunde". Healthy subjects will be recruited by public announcements on the University Hospital's and the University's notice board and website.
Who may be able to join
- Patients with thalamic central post-stroke pain (CPSP) :
- Patients fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- History of thalamic stroke (infarction or bleed)
- Diagnosis of definite central-post stroke pain (according to the criteria proposed by Klit et al, 2009)
- No other chronic pain condition
Show all 25Show fewer
- Age: ≥18 years old
- Patients with thalamic stroke without CPSP:
- Patients fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- History of thalamic stroke (infarction or bleed), at least 2 years ago
- No chronic pain condition (neither CPSP or other pain condition)
- Age ≥18 years old
- Patients with migraine (other pain condition):
- Patients fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- History of highly frequent (≥8 monthly migraine days) or chronic migraine (≥15 monthly migraine days).
- No history of stroke
- Age ≥18 years old
- Healthy controls:
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- No history of stroke
- No chronic pain condition
- Age: ≥18 years old
Who cannot join
- History of severe neurological, internistic or psychiatric disease
- MRI related exclusion criteria:
- paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the brain)
- Pacemaker
- Claustrophobia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Neurology
Basel, 4031
About this study
The goal of this observational study is to examine the association between exact lesion location and presence of thalamic CPSP (Central post-stroke pain) in a larger number of patients after thalamic stroke.
Read the detailed description
The researchers will explore how the brain areas and mechanisms of brain plasticity are involved in the generation of thalamic CPSP, compared to other pain disorders, using structural and functional magnetic resonance imaging (MRI) at 3 Tesla. The functional magnetic resonance imaging (fMRI) will be also used to assess the cerebral processing of heat/cold stimuli in patients with thalamic pain compared to thalamic stroke patients without pain, to patients with migraine (other central pain disorder) and to normal controls. In addition the researchers want to assess the somatosensory profile of thalamic pain patients and compare it with thalamic stroke patients without pain, patients with migraine (pain control) and normal controls.
- Conditions
- Central Post-stroke Pain
- Being tested
- Quantitative sensory testing (QST), Magnetic resonance imaging (MRI), Clinical interview/exam, Follow-up interview
- Keywords
- thalamic pain, thalamic stroke, chronic pain, sensory abnormalities, pain disorder, migraine
- Medical subject headings
- Chronic Pain, Somatoform Disorders, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testing (QST)Diagnostic test
The QST is a standardized, internationally accepted test battery consisting of several well-established, non-invasive tests, measuring parameters, which reflect nearly all aspects of somatosensation.
- Thermal detection threshold for the perception of cold, warm and paradoxical heat sensations
- Thermal pain threshold
- Mechanical detection thresholds for touch
- Mechanical pain threshold for pinprick stimuli
- Stimulus-response functions
- Wind- up ratio: The wind- up ratio represents the quotient of the pain intensity evoked by 10 pin-prick stimuli and the pain intensity evoked by one single pin-prick stimulus
- Vibration detection threshold
- Pressure pain threshold
Magnetic resonance imaging (MRI)Diagnostic test
Functional and structural MRI data will be collected using a 3 Tesla Siemens Scanner with a multi-channel head coil.
For the resting state functional MRI the subjects will merely lie in the scanner for about 10 minutes.
A "painful heat/cold stimulation" will be performed to study the differences in pain processing between the three groups
Clinical interview/examOther
The pain characteristics will be assessed through a standardized questionnaire. The german pain questionnaire is a validated questionnaire that assesses various dimensions of pain. Patients will also get a complete neurological examination by an experienced clinician.
Follow-up interviewOther
Structured telephone interview with 3 Questionnaires
- The german pain questionnaire
- Questionnaire regarding clinical development since the last visit designed by the investigators
- German translation of 12-item-allodynia symptom checklist (ASC-12)
| Study group | Role | What they receive |
|---|---|---|
| Patients with thalamic CPSP (central post-stroke pain) | Patients with CPSP of thalamic origin due to stroke. Receives: Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI); Other: Clinical interview/exam; Other: Follow-up interview | |
| Patients with thalamic stroke without CPSP | Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders Receives: Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI); Other: Clinical interview/exam; Other: Follow-up interview | |
| Patients with migraine | Patients with migraine (other central pain disorder) Receives: Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI); Other: Clinical interview/exam | |
| Healthy controls | Age- and gender-matched healthy control subjects Receives: Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain
To determine the mutual lesion location in patients with CPSP of thalamic origin in standard stereotactic space using high-resolution 3 T MRI data and to calculate odds ratio maps for the risk of developing CPSP of thalamic origin with lesion of specific areas of the thalamus.
Measured: One time assessment with a duration of max. 90 minutes.
Secondary outcomes (5)
Structural gray matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
The 3 dimensional MPRAGE images will be used to assess cortical thickness and subcortical morphometry
Measured: One time assessment with a duration of max. 90 minutes.
Structural white matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
Diffusion Tensor Imaging (DTI) will be used to asess the integrity of the white matter
Measured: One time assessment with a duration of max. 90 minutes.
Functional brain changes regarding the connectivity of pain networks in patients with thalamic pain compared to the other patient groups and the healthy controls
Resting state fMRI (functional MRI) will be used to assess the functional connectivity between the thalamus and cortical areas next to the default-mode network and the sensory-motor network.
Measured: One time assessment with a duration of max. 90 minutes.
Functional brain changes regarding the central processing of heat/cold stimulation in patients with thalamic pain compared to the other patient groups and the healthy controls
Painful heat- and cold stimulation will be performed during the fMRI session at one time-point to assess the central processing of pain in all participants
Measured: One time assessment with a duration of max. 90 minutes.
Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)
Somatosensory profile will be assessed by quantitative sensory testing (QST). This standardized, internationally accepted test battery consists of well-established, non-invasive tests, which are performed on the face, hand or foot of the participants. The tests measure parameters which reflect nearly all aspects of somatosensation (thermal detection thresholds, thermal pain thresholds, mechanical detection thresholds for touch, mechanical pain threshold, mechanical allodynia, vibration detection threshold and pressure pain threshold).
Measured: One time assessment with a duration of max. 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start4 May 2015
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Post-stroke PainStudies of the same condition, open and under way.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- European Pain Federation
- Responsible party
- Sponsor
- Investigators
- Athina Papadopoulou, PD Dr. med., Principal investigator, University Hospital Basel, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679297
- Sponsor's protocol ID
- 2022-00028; ko22Papadopoulou
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders
- ClinicalTrials.gov ID
- NCT05679297
- Acronym / sponsor ID
- 2022-00028; ko22Papadopoulou
- Conditions
- Central Post-stroke Pain
- Keywords
- thalamic pain, thalamic stroke, chronic pain, sensory abnormalities, pain disorder, migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- European Pain Federation
- Study start
- 4 May 2015 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 10 Jan 2023 (actual)
- 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.
The goal of this observational study is to examine the association between exact lesion location and presence of thalamic CPSP (Central post-stroke pain) in a larger number of patients after thalamic stroke.
Detailed description
The researchers will explore how the brain areas and mechanisms of brain plasticity are involved in the generation of thalamic CPSP, compared to other pain disorders, using structural and functional magnetic resonance imaging (MRI) at 3 Tesla. The functional magnetic resonance imaging (fMRI) will be also used to assess the cerebral processing of heat/cold stimuli in patients with thalamic pain compared to thalamic stroke patients without pain, to patients with migraine (other central pain disorder) and to normal controls. In addition the researchers want to assess the somatosensory profile of thalamic pain patients and compare it with thalamic stroke patients without pain, patients with migraine (pain control) and normal controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with thalamic CPSP (central post-stroke pain) | – | Diagnostic Test: Quantitative sensory testing (QST), Diagnostic Test: Magnetic resonance imaging (MRI), Other: Clinical interview/exam, Other: Follow-up interviewPatients with CPSP of thalamic origin due to stroke. |
| Patients with thalamic stroke without CPSP | – | Diagnostic Test: Quantitative sensory testing (QST), Diagnostic Test: Magnetic resonance imaging (MRI), Other: Clinical interview/exam, Other: Follow-up interviewPatients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders |
| Patients with migraine | – | Diagnostic Test: Quantitative sensory testing (QST), Diagnostic Test: Magnetic resonance imaging (MRI), Other: Clinical interview/examPatients with migraine (other central pain disorder) |
| Healthy controls | – | Diagnostic Test: Quantitative sensory testing (QST), Diagnostic Test: Magnetic resonance imaging (MRI)Age- and gender-matched healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment of patients with thalamic pain will take place at the Department of Neurology, University Hospital Basel in collaboration with the chronic pain service of the Department of Anesthesiology, University Hospital Basel and the "Schmerzklinik Kirschgarten" in Basel. The recruitment of patients with thalamic stroke without pain as well as of patients with migraine (other pain disorder) will take place at the Department of Neurology, University Hospital Basel, the latter especially from the "Kopfsprechstunde". Healthy subjects will be recruited by public announcements on the University Hospital's and the University's notice board and website.
Key inclusion criteria (25 listed)
- Patients with thalamic central post-stroke pain (CPSP) :
- Patients with thalamic stroke without CPSP:
- Patients with migraine (other pain condition):
- Healthy controls:
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
Key exclusion criteria (6 listed)
- History of severe neurological, internistic or psychiatric disease
- MRI related exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testing (QST)The QST is a standardized, internationally accepted test battery consisting of several well-established, non-invasive tests, measuring parameters, which reflect nearly all aspects of somatosensation. 1. Thermal detection threshold for the perception of cold, warm and paradoxical heat sensations 2. Thermal pain threshold 3. Mechanical detection thresholds for touch 4. Mechanical pain threshold for pinprick stimuli 5. Stimulus-response functions 6. Wind- up ratio: The wind- up ratio represents the quotient of the pain intensity evoked by 10 pin-prick stimuli and the pain intensity evoked by one single pin-prick stimulus 7. Vibration detection threshold 8. Pressure pain threshold | Diagnostic test | Healthy controls, Patients with migraine, Patients with thalamic CPSP (central post-stroke pain), Patients with thalamic stroke without CPSP |
| Magnetic resonance imaging (MRI)Functional and structural MRI data will be collected using a 3 Tesla Siemens Scanner with a multi-channel head coil. For the resting state functional MRI the subjects will merely lie in the scanner for about 10 minutes. A "painful heat/cold stimulation" will be performed to study the differences in pain processing between the three groups | Diagnostic test | Healthy controls, Patients with migraine, Patients with thalamic CPSP (central post-stroke pain), Patients with thalamic stroke without CPSP |
| Clinical interview/examThe pain characteristics will be assessed through a standardized questionnaire. The german pain questionnaire is a validated questionnaire that assesses various dimensions of pain. Patients will also get a complete neurological examination by an experienced clinician. | Other | Patients with migraine, Patients with thalamic CPSP (central post-stroke pain), Patients with thalamic stroke without CPSP |
| Follow-up interviewStructured telephone interview with 3 Questionnaires 1. The german pain questionnaire 2. Questionnaire regarding clinical development since the last visit designed by the investigators 3. German translation of 12-item-allodynia symptom checklist (ASC-12) | Other | Patients with thalamic CPSP (central post-stroke pain), Patients with thalamic stroke without CPSP |
Primary outcome
The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain
Time frame: One time assessment with a duration of max. 90 minutes.
To determine the mutual lesion location in patients with CPSP of thalamic origin in standard stereotactic space using high-resolution 3 T MRI data and to calculate odds ratio maps for the risk of developing CPSP of thalamic origin with lesion of specific areas of the thalamus.
5 secondary outcomes
Structural gray matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
Time frame: One time assessment with a duration of max. 90 minutes.
Structural white matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
Time frame: One time assessment with a duration of max. 90 minutes.
Functional brain changes regarding the connectivity of pain networks in patients with thalamic pain compared to the other patient groups and the healthy controls
Time frame: One time assessment with a duration of max. 90 minutes.
Functional brain changes regarding the central processing of heat/cold stimulation in patients with thalamic pain compared to the other patient groups and the healthy controls
Time frame: One time assessment with a duration of max. 90 minutes.
Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)
Time frame: One time assessment with a duration of max. 60 minutes.
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.
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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.
Athina Papadopoulou, PD Dr. med. principal investigator
University Hospital Basel, Department of Neurology
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 Central Post-stroke Pain, run by University Hospital, Basel, Switzerland 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 25 inclusion and 6 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?
The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain (time frame: One time assessment with a duration of max. 90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.