Structural and Functional Grey and White Matter Changes in Patients With Pain Disorders

Completed

• Conditions: Central Post-stroke Pain
• Interventions: Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI); Other: Clinical interview/exam; Other: Follow-up interview

• Registration Number: NCT05679297
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2015-05-04
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with thalamic CPSP (central post-stroke pain)	Quantitative sensory testing (QST)	Patients with CPSP of thalamic origin due to stroke.
Patients with thalamic CPSP (central post-stroke pain)	Follow-up interview	Patients with CPSP of thalamic origin due to stroke.
Patients with thalamic stroke without CPSP	Follow-up interview	Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders
Patients with thalamic CPSP (central post-stroke pain)	Magnetic resonance imaging (MRI)	Patients with CPSP of thalamic origin due to stroke.
Patients with thalamic stroke without CPSP	Clinical interview/exam	Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders
Patients with migraine	Quantitative sensory testing (QST)	Patients with migraine (other central pain disorder)
Patients with thalamic stroke without CPSP	Magnetic resonance imaging (MRI)	Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders
Patients with thalamic CPSP (central post-stroke pain)	Clinical interview/exam	Patients with CPSP of thalamic origin due to stroke.
Patients with migraine	Magnetic resonance imaging (MRI)	Patients with migraine (other central pain disorder)
Patients with migraine	Clinical interview/exam	Patients with migraine (other central pain disorder)
Patients with thalamic stroke without CPSP	Quantitative sensory testing (QST)	Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders
Healthy controls	Quantitative sensory testing (QST)	Age- and gender-matched healthy control subjects
Healthy controls	Magnetic resonance imaging (MRI)	Age- and gender-matched healthy control subjects

Primary Outcome Measures

Name	Time	Method
The exact lesion location in the thalamus in patients with thalamic pain compared to patients with thalamic stroke without pain	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.

Secondary Outcome Measures

Name	Time	Method
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	One time assessment with a duration of max. 90 minutes.	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
Functional brain changes regarding the connectivity of pain networks in patients with thalamic pain compared to the other patient groups and the healthy controls	One time assessment with a duration of max. 90 minutes.	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.
Structural white matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls	One time assessment with a duration of max. 90 minutes.	Diffusion Tensor Imaging (DTI) will be used to asess the integrity of the white matter
Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)	One time assessment with a duration of max. 60 minutes.	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).
Structural gray matter changes in patients with thalamic pain compared to the other patient groups and the healthy controls	One time assessment with a duration of max. 90 minutes.	The 3 dimensional MPRAGE images will be used to assess cortical thickness and subcortical morphometry

Trial Locations

Locations (1)

University Hospital Basel, Department of Neurology; 🇨🇭 Basel, Switzerland