Motor Cortex Stimulation for Post-Stroke Thalamic Pain

NCT07758829 | Not Yet Recruiting

• 1 other identifier: L2608108
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Central Post-stroke Pain; Stroke; Electric Stimulation Therapy; Multimodal Imaging

Keywords

Post-Stroke Thalamic Pain; Motor Cortex Stimulation; Neuromodulation; Multimodal Magnetic Resonance Imaging; Predictive Biomarkers; Brain Networks

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  6 months post-surgery

Secondary Outcomes (10)

• 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 SF-36 Quality of Life 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

Study Arms (1)

Motor Cortex Stimulation (MCS)

EXPERIMENTAL

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.

Device: Motor Cortex Stimulation (MCS) System

Interventions

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).

Motor Cortex Stimulation (MCS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerospace Center Hospital: lead

MeSH Terms

Conditions

Stroke

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Mingming Zhao, Doctor of Medicine(M.D.)

CONTACT

86-18600317173; mingming157@163.com

Di Lu, Doctor of Medicine(M.D.)

CONTACT

86-17865195209; ludisdu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Neurosurgery

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share