Motor Cortex Stimulation for Post-Stroke Thalamic Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAerospace Center Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of alcohol, drug, or substance abuse or dependence within the past 12 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Motor Cortex Stimulation (MCS) System

    Device

    Epidural paddle electrodes implanted over the primary motor cortex (M1) and adjacent premotor areas, connected to an implantable pulse generator. The system delivers programmed electrical stimulation (40 Hz, 200 μs pulse width) for pain modulation in patients with post-stroke thalamic pain. Devices used in this study: electrode model L3251 and pulse generator model G122R (provided by Beijing Pins Medical Co., Ltd., China).

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Motor Cortex Stimulation (MCS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Short-term Response Rate

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.

Time frame
2 weeks post-stage I surgery (at the end of external trial period)
2

Long-term Response Rate

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.

Time frame
6 months post-surgery

Secondary outcomes

1

Change in McGill Pain Questionnaire Short-Form (SF-MPQ) Score

Change in SF-MPQ total score from baseline to each follow-up time point.

Time frame
Baseline, 2 weeks, 3 months, 6 months
2

Change in Pain Catastrophizing Scale (PCS) Score

Change in PCS total score from baseline to each follow-up time point.

Time frame
Baseline, 2 weeks, 3 months, 6 months
3

Change in SF-36 Quality of Life Score

Time frame
Baseline, 2 weeks, 3 months, 6 months
4

Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time frame
Baseline, 2 weeks, 3 months, 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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