NCT07758829Not yet recruiting
Motor Cortex Stimulation for Post-Stroke Thalamic Pain
A Study on Mechanisms and Predictive Factors of Motor Cortex Stimulation for Post-Stroke Thalamic Pain Based on Multimodal Imaging
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Aerospace Center Hospital
- Diseases
- Stroke
- NCT number
- NCT07758829
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Sept 2026 to the primary completion date, 31 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.