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

NCT05679297 | Completed

• 1 other identifier: 2022-00028; ko22Papadopoulou
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Post-stroke Pain

Keywords

thalamic pain; thalamic stroke; chronic pain; sensory abnormalities; pain disorder; migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  One time assessment with a duration of max. 90 minutes.

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

  One time assessment with a duration of max. 60 minutes.

Other Outcomes (2)

• Assessment of severity and characteristics of pain.

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

• Longitudinal evaluation of clinical development in CPSP

  One time assessment with a duration of max. 10 minutes.

Study Arms (4)

Patients with thalamic CPSP (central post-stroke pain)

Patients with CPSP of thalamic origin due to stroke.

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

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)

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

Diagnostic Test: Quantitative sensory testing (QST); Diagnostic Test: Magnetic resonance imaging (MRI)

Interventions

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. 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

Healthy controls; Patients with migraine; Patients with thalamic CPSP (central post-stroke pain); Patients with thalamic stroke without CPSP

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

Healthy controls; Patients with migraine; Patients with thalamic CPSP (central post-stroke pain); Patients with thalamic stroke without CPSP

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.

Patients with migraine; Patients with thalamic CPSP (central post-stroke pain); Patients with thalamic stroke without CPSP

Follow-up interview OTHER

Structured 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)

Patients with thalamic CPSP (central post-stroke pain); Patients with thalamic stroke without CPSP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with thalamic central post-stroke pain (CPSP) :
• 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:
• 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):
• 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

You may not qualify if:

• History of severe neurological, internistic or psychiatric disease
• paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the brain)
• Pacemaker
• Claustrophobia
• Pregnancy

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• European Pain Federation: collaborator

Study Sites (1)

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders; Migraine Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Athina Papadopoulou, PD Dr. med.

  University Hospital Basel, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: May 4, 2015
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

CH (1)