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

NCT ID: NCT05679297

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-04
• Study Completion Date: 2024-12-27

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.

Conditions

Central Post-stroke Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with thalamic CPSP (central post-stroke pain)

Patients with CPSP of thalamic origin due to stroke.

Quantitative sensory testing (QST)

Intervention Type: 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

Magnetic resonance imaging (MRI)

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 stroke without CPSP

Patients with thalamic stroke at least 2 years ago, but without CPSP or other chronic pain disorders

Quantitative sensory testing (QST)

Intervention Type: 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

Magnetic resonance imaging (MRI)

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 migraine

Patients with migraine (other central pain disorder)

Quantitative sensory testing (QST)

Intervention Type: 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

Magnetic resonance imaging (MRI)

Intervention Type: 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

Intervention Type: 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.

Healthy controls

Age- and gender-matched healthy control subjects

Quantitative sensory testing (QST)

Intervention Type: 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

Magnetic resonance imaging (MRI)

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Clinical interview/exam

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.

Intervention Type: OTHER

Follow-up interview

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. 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
• Age ≥18 years old

4. Healthy controls:

• 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

• paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the brain)
• Pacemaker
• Claustrophobia
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Pain Federation

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athina Papadopoulou, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Neurology

Locations

University Hospital Basel, Department of Neurology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2022-00028; ko22Papadopoulou

Identifier Type: -

Identifier Source: org_study_id