An observational study in Central Post-stroke Pain, Thalamic Pain Syndrome and Stroke, sponsored by Aerospace Center Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Aerospace Center Hospital · Observational
The goal of this retrospective observational study is to analyze multimodal imaging (including CT, MRI, and other imaging modalities), clinical characteristics, and laboratory findings from patients with post-stroke thalamic pain who were treated at Aerospace Center Hospital between September 2023 and September 2026.
The main questions this study aims to answer are:
What are the structural and functional brain imaging features (derived from CT, T1, DTI, and resting-state fMRI) that distinguish patients with different pain severity levels? What are the metabolic profiles (measured by MRS) in pain-related brain regions (thalamus, anterior cingulate cortex, insula) in these patients? Are there correlations between imaging biomarkers, clinical pain scores, and laboratory parameters? Researchers will review and analyze existing medical records, imaging data (including CT and MRI scans), and laboratory test results from routine clinical care. All data have already been collected as part of standard patient care. No additional interventions, tests, or patient visits are required for this study. This is a purely retrospective data analysis study.
Background and Rationale
Post-stroke thalamic pain is a debilitating central neuropathic pain condition that significantly affects patients' quality of life. While advances in neuroimaging have improved our understanding of brain structural and functional alterations in chronic pain, comprehensive characterization of multimodal imaging features-including both CT and MRI modalities-in this specific patient population remains limited. CT imaging provides valuable information on lesion localization, calcification, and vascular changes, while MRI offers superior soft tissue contrast for assessing white matter integrity, functional connectivity, and metabolic profiles. A systematic retrospective analysis integrating multiple imaging modalities with clinical and laboratory data may help identify imaging biomarkers associated with pain severity and provide insights into the underlying neural mechanisms.
Study Design
This is a single-center, retrospective observational study conducted at Aerospace Center Hospital, Beijing, China. All patients diagnosed with post-stroke thalamic pain between September 2023 and September 2026 will be screened for eligibility. This study involves no prospective intervention, no additional patient visits, and no extra imaging or laboratory tests. All data will be extracted from existing electronic medical records and hospital databases.
Data Collection
The following data will be systematically extracted from electronic medical records and imaging archives:
Demographic and Clinical Characteristics: Age, sex, stroke type (ischemic/hemorrhagic), stroke laterality, pain duration, medication history, and comorbidities.
Pain Assessments: Visual Analog Scale (VAS) scores, McGill Pain Questionnaire (SF-MPQ) scores, and Pain Catastrophizing Scale (PCS) scores recorded during routine clinical visits.
Multimodal Imaging Data: Comprehensive imaging data will be collected, including:
CT: Lesion localization, calcification patterns, and structural changes MRI Structural: High-resolution T1-weighted imaging for volumetric analysis; Diffusion Tensor Imaging (DTI) with 64 diffusion directions for white matter tractography and pathway integrity assessment MRI Functional: Resting-state functional MRI (rs-fMRI) for functional connectivity analysis MRI Metabolic: Magnetic Resonance Spectroscopy (MRS) targeting bilateral thalamus, anterior cingulate cortex, and insula for quantification of glutamate (Glu), GABA, N-acetylaspartate (NAA), choline (Cho), and creatine (Cr) concentrations Laboratory Parameters: Routine blood tests, inflammatory markers (CRP, ESR), and other available biochemical parameters.
Study Population
Patients with a confirmed diagnosis of post-stroke thalamic pain (stroke localized to the thalamus) who received care at Aerospace Center Hospital during the study period. All patients are aged 18-80 years at the time of diagnosis. Patients with incomplete records, poor image quality, or other neurological disorders that could confound the analysis will be excluded.
Analytical Plan
Descriptive Analysis: Demographic and clinical characteristics will be summarized using descriptive statistics. Continuous variables will be reported as mean ± standard deviation or median with interquartile range, and categorical variables as frequencies and percentages.
Group Comparisons: Patients will be stratified by pain severity (e.g., mild-to-moderate vs. severe based on VAS scores). Group differences in imaging metrics (FA values, functional connectivity strength, metabolite concentrations) and laboratory parameters will be compared using independent t-tests or Mann-Whitney U tests, as appropriate.
Correlation Analysis: Pearson or Spearman correlation analyses will be performed to examine associations between:
Imaging biomarkers (structural, functional, metabolic) and clinical pain scores Laboratory parameters and pain severity Imaging biomarkers and laboratory findings Multivariable Regression: Stepwise multivariable linear or logistic regression models will be constructed to identify independent factors associated with pain severity. Candidate predictors will include demographic variables, imaging metrics, and laboratory parameters. The final model will be evaluated using R² and AIC/BIC criteria.
Subgroup Analyses: Exploratory subgroup analyses will be conducted by stroke type (ischemic vs. hemorrhagic), lesion laterality (left vs. right), and age groups (\<60 vs. ≥60 years) to assess the consistency of findings across clinically relevant subgroups.
Statistical Software: All statistical analyses will be performed using SPSS (version 26.0) and R (version 4.1.0 or later). The significance level will be set at α = 0.05 (two-sided). For multiple comparisons, false discovery rate (FDR) correction will be applied where appropriate.
Data Management and Quality Control
All data will be collected and stored in a secure, password-protected electronic database. Patient identifiers will be removed to ensure anonymity. Data quality will be ensured through: (1) standardized data extraction forms; (2) double data entry for a random subset to verify accuracy; (3) range checks for all continuous variables; and (4) systematic review by two independent researchers for image quality and data completeness. All data handling will comply with hospital data protection policies and relevant Chinese regulations on medical data privacy.
Ethical Considerations
This study will be conducted in accordance with the Declaration of Helsinki and relevant Chinese regulations. Approval from the Medical Ethics Committee of Aerospace Center Hospital will be obtained prior to data extraction. A waiver of informed consent will be sought, given the retrospective nature of the study, the minimal risk to participants, and the anonymization of all data.
Expected Significance
This comprehensive retrospective analysis of multimodal imaging, clinical, and laboratory data is expected to:
Characterize the imaging phenotype of post-stroke thalamic pain across multiple modalities (CT and MRI) Identify imaging biomarkers associated with pain severity Elucidate potential correlations between imaging findings, clinical measures, and laboratory parameters Provide a foundation for future prospective studies on personalized pain management The findings may inform clinical decision-making by highlighting key imaging and laboratory parameters that correlate with pain presentation and potentially guide patient stratification for future therapeutic interventions.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 50 is below the median of 160 across 1,729 observational studies indexed under Stroke.
Browse Stroke studies →Aerospace Center Hospital is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include patients diagnosed with post-stroke thalamic pain who received routine clinical care at the Department of Neurosurgery, Aerospace Center Hospital, Beijing, China, between September 2023 and September 2026. All data (including demographic information, clinical assessments, multimodal imaging, and laboratory results) were collected as part of standard clinical practice prior to the initiation of this study. Patients were identified through the hospital's electronic medical record system and imaging archive (PACS). The source population represents a consecutive series of patients meeting the diagnostic criteria for post-stroke thalamic pain during the specified time period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients diagnosed with post-stroke thalamic pain who underwent clinical evaluation, multimodal imaging (including CT and MRI), and laboratory testing at Aerospace Center Hospital between September 2023 and September 2026.
Pain severity assessed by Visual Analog Scale (VAS)
VAS scores extracted from medical records. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain severity.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Pain severity assessed by Short-Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ is a validated self-report measure of pain quality and intensity. It includes a 15-item Pain Rating Index (PRI; 11 sensory and 4 affective descriptors, each scored 0-3; total PRI range 0-45), a Present Pain Intensity (PPI) index (0-5), and a VAS (0-10). Higher PRI, PPI, and VAS scores indicate greater pain severity. Sensory scores reflect pain quality, while affective scores reflect pain-related emotional distress. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-report scale measuring catastrophic thoughts and feelings about pain. Each item is scored 0-4, giving a total score range of 0-52. It includes three subscales: rumination, magnification, and helplessness. Higher total scores indicate greater pain catastrophizing; a total score ≥30 is commonly used to indicate clinically relevant catastrophizing. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Fractional anisotropy (FA) of corticothalamic pathways
FA values measured from DTI. Higher FA indicates greater white matter integrity.
Time frame: Baseline (preoperative).
Thalamic gray matter volume
Gray matter volume of the thalamus measured from high-resolution T1-weighted MRI.
Time frame: Baseline (preoperative).
Resting-state functional connectivity within the default mode network (DMN)
Resting-state functional connectivity within the DMN was calculated from rs-fMRI data as the correlation of spontaneous BOLD signal fluctuations among key DMN regions (e.g., medial prefrontal cortex, posterior cingulate cortex/precuneus, and lateral parietal cortex). Values are typically Fisher z-transformed correlation coefficients; higher values indicate stronger within-network functional connectivity. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Resting-state functional connectivity within the salience network (SN)
Resting-state functional connectivity within the SN was calculated from rs-fMRI data as the correlation of spontaneous BOLD signal fluctuations among key SN regions (e.g., anterior insula and dorsal anterior cingulate cortex). Values are typically Fisher z-transformed correlation coefficients; higher values indicate stronger within-network functional connectivity. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Resting-state functional connectivity within the sensorimotor network (SMN)
Resting-state functional connectivity within the SMN was calculated from rs-fMRI data as the correlation of spontaneous BOLD signal fluctuations among key SMN regions (e.g., primary sensorimotor cortex, supplementary motor area, and premotor cortex). Values are typically Fisher z-transformed correlation coefficients; higher values indicate stronger within-network functional connectivity. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Glutamate/GABA ratio in the thalamus
Glutamate/GABA ratio measured by MRS in the thalamus.Glutamate is the main excitatory neurotransmitter and GABA the main inhibitory neurotransmitter; the ratio reflects the balance between excitation and inhibition in this region. Higher values indicate relatively increased excitatory or decreased inhibitory tone. The ratio is unitless. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Glutamate/GABA ratio in the anterior cingulate cortex (ACC)
Glutamate/GABA ratio measured by MRS in the ACC.Glutamate is the main excitatory neurotransmitter and GABA the main inhibitory neurotransmitter; the ratio reflects the balance between excitation and inhibition in this region. Higher values indicate relatively increased excitatory or decreased inhibitory tone. The ratio is unitless. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Glutamate/GABA ratio in the insula
Glutamate/GABA ratio measured by MRS in the insula.Glutamate is the main excitatory neurotransmitter and GABA the main inhibitory neurotransmitter; the ratio reflects the balance between excitation and inhibition in this region. Higher values indicate relatively increased excitatory or decreased inhibitory tone. The ratio is unitless. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
C-reactive protein (CRP) level
Serum CRP concentration measured from routine blood tests. CRP is an acute-phase reactant and a marker of systemic inflammation; higher levels indicate greater inflammatory activity. Values are typically reported in mg/L, and reference ranges may vary by laboratory. Data were extracted retrospectively from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Erythrocyte sedimentation rate (ESR)
ESR was measured from routine blood tests. It is a nonspecific marker of systemic inflammation; higher values indicate greater inflammatory activity. ESR is typically reported in mm/h, with reference ranges varying by laboratory and slightly higher in women. Data were extracted retrospectively from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Quality of life assessed by SF-36
The SF-36 is a 36-item, validated self-report questionnaire measuring health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. It generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a validated 19-item self-report questionnaire assessing sleep quality over the past month. It yields seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction), each scored 0-3, and a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality; a global score \>5 is commonly used to indicate poor sleep quality. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Depression assessed by Hamilton Depression Rating Scale (HAMD)
The HAMD is a clinician-administered scale assessing the severity of depressive symptoms over the past week. The 17-item version yields a total score of 0-52, with higher scores indicating more severe depression. Commonly used severity ranges are: 0-7 normal, 8-16 mild, 17-23 moderate, and ≥24 severe. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Anxiety assessed by Hamilton Anxiety Rating Scale (HAMA)
The HAMA is a clinician-administered scale assessing the severity of anxiety symptoms. The 14-item version yields a total score of 0-56, with higher scores indicating more severe anxiety. Commonly used severity ranges are: 0-6 no anxiety, 7-13 mild, 14-20 moderate, 21-28 severe, and ≥29 very severe. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Cognitive function assessed by Montreal Cognitive Assessment (MoCA)
The MoCA is a validated 30-point clinician-administered screening tool for cognitive impairment. It assesses attention, executive function, memory, language, visuospatial ability, abstraction, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function. A score \<26 is commonly used to indicate possible cognitive impairment (1 point is added for individuals with ≤12 years of education). Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Cognitive function assessed by Mini-Mental State Examination (MMSE)
The MMSE is a validated 30-point clinician-administered screening tool for cognitive impairment. It assesses orientation, registration, attention and calculation, recall, language, and visuospatial ability. Total scores range from 0 to 30, with higher scores indicating better cognitive function. A score ≤23 (or \<24, depending on education level) is commonly used to indicate possible cognitive impairment. Scores were extracted from medical records.
Time frame: Baseline (preoperative), 1 month postoperative, 6 months postoperative, and 12 months postoperative.
Global efficiency of the anatomical structural network based on T1-weighted MRI
T1-weighted MRI data are used to construct an individual anatomical structural network. Global efficiency is calculated as a summary metric of network integration. Higher global efficiency indicates stronger structural network integration.
Time frame: Baseline (preoperative).
Global cortical structural similarity based on T1-weighted MRI
A global summary metric of cortical structural similarity was calculated from T1-weighted MRI. This metric estimates the morphometric similarity between cortical regions based on their structural differences. The global mean similarity value was used as a single summary measure. Higher values indicate greater structural similarity across cortical regions. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Local efficiency of the anatomical structural network based on T1-weighted MRI
Local efficiency was calculated from the individual anatomical structural network constructed from T1-weighted MRI. It quantifies the efficiency of information transfer among neighboring nodes within local subnetworks. Higher values indicate greater local network integration. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Mean nodal efficiency of pre-specified key brain regions based on T1-weighted MRI
Nodal efficiency was calculated for pre-specified key brain regions (e.g., thalamus, anterior cingulate cortex, and insula) from the individual anatomical structural network constructed from T1-weighted MRI. The mean nodal efficiency across these regions was used as a single summary metric. Higher values indicate greater efficiency of information transfer through these regions. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Small-worldness of the anatomical structural network based on T1-weighted MRI
Small-worldness was calculated from the individual anatomical structural network constructed from T1-weighted MRI. It reflects the balance between local clustering and global integration. Values \>1 generally indicate a small-world organization. Data were extracted retrospectively from imaging archives.
Time frame: Baseline (preoperative).
Plan to share: No — Individual participant data (IPD) will not be shared because this is a retrospective observational study based on existing medical records and imaging data from routine clinical care. The data contain potentially identifiable patient information, and the study did not obtain informed consent for data sharing with external researchers. Data access will be limited to the primary research team for the purposes of this analysis only, in compliance with hospital data protection policies and Chinese regulations on medical data privacy.
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Ran from Sep 2023 to primary completion in Aug 2026, 35 months.
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Aerospace Center Hospital