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NCT Number: NCT05679297

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

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.

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Key information

Conditions

Central Post-stroke Pain Brain Diseases Central Nervous System Diseases Chronic Pain Headache Disorders Headache Disorders, Primary Mental Disorders Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

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

Treatment and study plan

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/exam

Other

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 Interview

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    The 3 dimensional MPRAGE images will be used to assess cortical thickness and subcortical morphometry

  2. 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.

    Diffusion Tensor Imaging (DTI) will be used to asess the integrity of the white matter

  3. 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.

    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.

  4. 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.

    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

  5. Somatosensory profile of patients with thalamic pain vs. migraine (pain-control-group)

    Time frame: 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).

Other outcomes

  1. Assessment of severity and characteristics of pain.

    Time frame: Two time assessment at baseline and 8-year-follow-up with a duration of max. 60 minutes.

    Pain characteristics will be assessed by the German pain questionnaire ("Deutscher Schmerzfragebogen"). It is a detailed questionnaire for the standardized collection of relevant pain characteristics, which is commonly used in the German language area. The first 8 items (sensory adjectives) represent a qualitative sensory description of pain that can provide information for the differential diagnosis of individual pain syndromes (e.g. headache, neuropathic pain). A summary evaluation is carried out for the affective scale. For this purpose, the total value (0-12) is formed from the individual ratings (each from 0 to 3) of the last four items (affective adjectives: miserable, horrid, horrible, terrible). A total value of 8 (corresponds to a percentage of 75%) can be set as the limit value for an increased affective experience of pain; values above this are to be assessed as conspicuous.

  2. Longitudinal evaluation of clinical development in CPSP

    Time frame: One time assessment with a duration of max. 10 minutes.

    The clinical development of CPSP will be assessed by an 8-year follow-up interview via phone call. The interview/questionnaire consists of 6 questions.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • European Pain Federation

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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