Clinical trial NCT05679297: Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders
Official title: Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Post-stroke Pain
Keywords: thalamic pain
thalamic stroke
chronic pain
sensory abnormalities
pain disorder
migraine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: European Pain Federation
First posted: 2023-01-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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
   * Age: ≥18 years old
2. 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
3. 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
4. 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain
timeFrame: One time assessment with a duration of max. 90 minutes.
Secondary outcomes:
measure: Structural gray matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
timeFrame: One time assessment with a duration of max. 90 minutes.
measure: Structural white matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls
timeFrame: One time assessment with a duration of max. 90 minutes.
measure: Functional brain changes regarding the connectivity of pain networks in patients with thalamic pain compared to the other patient groups and the healthy controls
timeFrame: One time assessment with a duration of max. 90 minutes.
measure: 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
timeFrame: One time assessment with a duration of max. 90 minutes.
measure: Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)
timeFrame: One time assessment with a duration of max. 60 minutes.
Other outcomes:
measure: Assessment of severity and characteristics of pain.
timeFrame: Two time assessment at baseline and 8-year-follow-up with a duration of max. 60 minutes.
measure: Longitudinal evaluation of clinical development in CPSP
timeFrame: One time assessment with a duration of max. 10 minutes.
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurology
Study officials:
affiliation: University Hospital Basel, Department of Neurology
name: Athina Papadopoulou, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: