A Study on Mechanisms and Predictive Factors of Motor Cortex Stimulation for Post-Stroke Thalamic Pain Based on Multimodal Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Short-term Response Rate
研究概览
简要总结
The goal of this clinical trial is to investigate the mechanisms and predictive factors of motor cortex stimulation (MCS) for treating post-stroke thalamic pain, a challenging central neuropathic pain condition. Approximately 25% of patients show no short-term response to MCS, and about 20% experience long-term efficacy decay, yet the underlying analgesic mechanisms remain unclear and objective predictive biomarkers are lacking.
This study aims to answer the following main questions:
How does MCS modulate thalamic pain through the coordinated interaction of structural connectivity, functional network dynamics, and metabolic balance in the brain? What are the distinct neuroimaging characteristics that differentiate short-term non-responders, long-term responders, and those with long-term efficacy decay? Which multimodal imaging biomarkers can reliably predict short-term and long-term MCS efficacy? Participants will undergo a two-stage MCS surgical procedure. In stage I, epidural electrodes are implanted over the motor cortex, followed by a 2-week external trial stimulation. Participants who achieve a ≥50% reduction in Visual Analog Scale (VAS) pain score will proceed to stage II, receiving an implanted pulse generator for long-term stimulation. Those who do not respond in the short term will have the electrodes removed without undergoing stage II implantation.
All participants will complete baseline clinical assessments and multimodal MRI scans (including T1, DTI, resting-state fMRI, and MRS) before surgery. Participants who receive the permanent implant will undergo follow-up clinical evaluations and repeat MRI scans at 3 and 6 months post-surgery.
Researchers will compare imaging features across three outcome groups-short-term non-responders, long-term responders, and long-term decay group-to identify predictive biomarkers. Multimodal imaging data will be integrated using LASSO regression to build prediction models for both short-term screening and long-term efficacy warning.
This research is expected to establish a "mechanism exploration - efficacy prediction - clinical decision" paradigm, providing objective imaging-based evidence to guide patient selection and postoperative management for MCS treatment.
详细描述
Background and Rationale
Post-stroke thalamic pain is a refractory central neuropathic pain condition that significantly impairs patients' quality of life. Motor cortex stimulation (MCS) has emerged as a promising neuromodulatory therapy, yet its clinical application faces two major challenges: approximately 25% of patients show inadequate short-term response during the external trial phase, and about 20% of initial responders experience progressive efficacy decay within six months of permanent implantation. The neural mechanisms underlying MCS analgesia remain incompletely understood, and objective predictors for patient selection and long-term outcome are lacking.
Study Design
This is a prospective, single-arm cohort study conducted at Aerospace Center Hospital, Beijing, China. A total of 200 patients with refractory post-stroke thalamic pain will be enrolled. All participants will undergo a standardized two-stage MCS surgical protocol. The study design incorporates comprehensive clinical assessments and multimodal MRI acquisition at baseline, with longitudinal follow-up at 3 and 6 months post-surgery for patients receiving permanent implants.
Surgical Protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years. Diagnosed with chronic post-stroke central pain with a pain duration of at least 1 year, with stroke localized to the thalamus.
- •Visual Analog Scale (VAS) pain score ≥ 5 at baseline. Poor response to or intolerance of conventional pharmacotherapy for pain. Medically suitable for surgical treatment (no coagulopathy, no infection at surgical site, no severe psychiatric disorders, etc.).
- •Voluntarily agrees to receive motor cortex stimulation (MCS) treatment. Able to communicate effectively with researchers and willing to comply with all study requirements.
- •Sufficient cognitive ability to use the patient programmer and patient programmer charger.
排除标准
- •History of alcohol, drug, or substance abuse or dependence within the past 12 months.
- •Trigeminal neuralgia or atypical facial pain. Advanced cardiovascular or other systemic disease that precludes surgical intervention.
- •Prior history of ablative or related intracranial surgery. Presence of other neurological disorders, such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, or brain/spinal cord tumors.
- •Implanted drug pump and/or another implantable device (e.g., cardiac pacemaker, defibrillator, cochlear implant, other neurostimulation systems such as spinal cord stimulator or deep brain stimulator).
- •Metastatic malignancy or untreated localized malignancy. Pregnancy, breastfeeding, planned pregnancy, or women of childbearing potential without reliable contraceptive measures.
- •Severe depression or anxiety (as determined by clinical assessment). Any other condition deemed unsuitable for participation by the investigator.
研究组 & 干预措施
Motor Cortex Stimulation (MCS)
All participants undergo the same two-stage motor cortex stimulation (MCS) surgical protocol. Stage I involves epidural electrode implantation over the motor cortex, followed by a 2-week external trial stimulation. Participants who achieve a ≥50% reduction in Visual Analog Scale (VAS) pain score proceed to Stage II for implantation of an internal pulse generator. Those who do not respond in the short term undergo electrode removal without permanent implantation. All participants receive programmed stimulation parameters (40 Hz, 200 μs pulse width) during the trial and long-term follow-up. Postoperative assessments are conducted at 3 and 6 months for those receiving permanent implants.
干预措施: Motor Cortex Stimulation (MCS) System (Device)
结局指标
主要结局
Short-term Response Rate
时间窗: 2 weeks post-stage I surgery (at the end of external trial period)
Proportion of participants achieving a ≥50% reduction in Visual Analog Scale (VAS) score from baseline at the end of the 2-week external trial stimulation period.
Long-term Response Rate
时间窗: 6 months post-surgery
Proportion of participants receiving permanent implantation who maintain a ≥50% reduction in Visual Analog Scale (VAS) score from baseline at 6 months post-surgery. This outcome is assessed only in participants who achieved short-term response and proceeded to Stage II implantation.
次要结局
- Change in SF-36 Quality of Life Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in McGill Pain Questionnaire Short-Form (SF-MPQ) Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in Pain Catastrophizing Scale (PCS) Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in Hamilton Depression Rating Scale (HAMD) Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in Hamilton Anxiety Rating Scale (HAMA) Score(Baseline, 2 weeks, 3 months, 6 months)
- Change in Montreal Cognitive Assessment (MoCA) Score(Baseline, 2 weeks, 3 months, 6 months)
- Longitudinal Changes in Multimodal MRI Biomarkers(Baseline, 3 months, 6 months)
- Adverse Event and Complication Rate(From enrollment through 6-month follow-up)
- Patient Global Impression of Change (PGIC) Score(2 weeks, 3 months, 6 months)
研究者
FengYin
Chief Physician, Department of Neurosurgery
Aerospace Center Hospital