Clinical Research Directory

Motor Cortex Stimulation for Post-Stroke Thalamic Pain

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.

Thalamic-Burst-DBS for Neuropathic Pain

Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke. Recently, a modified stimulation paradigm has been developed in the field of spinal cord stimulation (SCS) for a variety of neuropathic pain disorders. To date, this stimulation paradigm has not yet been evaluated systematically for deep brain stimulation to treat neuropathic pain disorders. The purpose of this clinical investigation is to investigate if Burst-DBS of the thalamus is more effective compared to classical continuous low-frequency stimulation DBS to reduce the subjective pain intensity in patients with chronic neuropathic pain after stroke or in patients with neuropathic facial pain.

Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome

Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.