Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients (HC-IBCI-SE-TMF)

Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia

This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury
• Intervention / Treatment: Other: Invasive BCI

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Chen, PhD; Phone Number: +862164041990; Email: chen.jing7@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai Zhongshan Hospital
      • Contact: Hao Wang, PhD; Phone Number: +8602164041990; Email: wang.hao@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years old (no gender restriction)
• Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury
• ≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function)
• Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT)
• Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20

Exclusion Criteria:

• Females who are pregnant
• History of drug abuse or alcoholism
• Diseases that limit limb mobility: fractures (progressive/deformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months
• Neurological diseases/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation
• Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis
• BMI ≥ 30.0 kg/m²
• Patients with depressive disorder (17-item Hamilton Depression Rating Scale [HAMD] score > 17)
• Patients unable to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IBCI; Receive invasive BCI intervention

Other: Invasive BCI; Main Study Phase: Subjects undergo intracranial electrode implantation surgery. After surgery, motor intention decoding is performed on the electroencephalographic (EEG) signals recorded by the intracranial electrodes, and the decoded signals drive an external hand continuous passive motion device to achieve upper limb grasping movements. Extension Phase: Subjects receive implantation of epidural spinal cord test electrodes, and undergo rehabilitation training with closed-loop epidural electrical stimulation based on signals from the implanted electrodes. Follow-up Phase: It mainly involves functional training with closed-loop epidural electrical stimulation based on scalp EEG signals, as well as follow-up observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grasping Success Rate	The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping	Before surgery and 1 week, 1 month, and 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grasping Object Type Coverage	The types of objects that can be accurately grasped (e.g., water cups, mobile phones, paper)	Before surgery and 1 week, 1 month, and 3 months after surgery
Brain-Controlled Command Recognition Accuracy	The correctness of converting electroencephalographic (EEG) signals into grasping commands	Before surgery and 1 week, 1 month, and 3 months after surgery
Grasping Latency	The time interval from when the brain generates a grasping intention to the execution of the grasping action	Before surgery and 1 week, 1 month, and 3 months after surgery
Manual Muscle Testing (MMT)	Change from baseline in muscle strength assessed using the Medical Research Council (MRC) Manual Muscle Testing scale (grade 0-5; higher grade indicates greater muscle strength/better outcome).	Before surgery and 1 week, 1 month, and 3 months after surgery
Modified Ashworth Scale (MAS) for Spasticity	Change from baseline in spasticity assessed using the Modified Ashworth Scale (MAS; 0-4 with a 1+ category; higher score indicates more severe spasticity/worse outcome).	Before surgery and 1 week, 1 month, and 3 months after surgery
3-Meter Walking Time	Change from baseline in time to complete a 3-meter walk, measured in seconds (s); lower time indicates better walking performance/better outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
Step Width (Motion Capture)	Change from baseline in step width measured by motion capture gait analysis, reported in centimeters (cm).	Before surgery and 1 week, 1 month, and 3 months after surgery
Step Length (Motion Capture)	Change from baseline in step length measured by motion capture gait analysis, reported in centimeters (cm); greater step length generally indicates better gait performance.	Before surgery and 1 week, 1 month, and 3 months after surgery
Step Height (Motion Capture)	Change from baseline in step height measured by motion capture gait analysis, reported in centimeters (cm).	Before surgery and 1 week, 1 month, and 3 months after surgery
Step Frequency (Motion Capture)	Change from baseline in step frequency measured by motion capture gait analysis, reported in steps per minute (steps/min); higher frequency generally indicates better gait performance.	Before surgery and 1 week, 1 month, and 3 months after surgery
Walking Speed (Motion Capture)	Change from baseline in walking speed measured by motion capture gait analysis, reported in centimeters per second (cm/s); higher speed indicates better gait performance/better outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
Plantar Pressure Value	Change from baseline in plantar peak pressure assessed using a plantar pressure measurement system, reported in kilopascals (kPa).	Before surgery and 1 week, 1 month, and 3 months after surgery
Limb Muscle Volume	Change from baseline in limb muscle volume assessed using imaging-based volumetry, reported in cubic centimeters (cm³); higher volume indicates greater muscle mass/better outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
Visual Analog Scale (VAS)	Change from baseline in pain intensity assessed using the Visual Analog Scale (VAS; 0-10, where 0 = no pain and 10 = worst pain imaginable); higher score indicates worse pain/worse outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W)	Change from baseline in male sexual function assessed using the Sexual Health Inventory for Men (SHIM; total score 1-25); higher score indicates better erectile function/better outcome. OR Change from baseline in female sexual complaints assessed using the Sexual Complaints Screener for Women (SCS-W; total score 0-60); higher score indicates greater symptom severity/worse outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention	Change from baseline in urinary symptoms assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; total score 0-21); higher score indicates more severe urinary symptoms/worse outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery
Neurogenic Bowel Dysfunction (NBD)	Change from baseline in bowel function assessed using the Neurogenic Bowel Dysfunction (NBD) score (total score 0-47); higher score indicates more severe bowel dysfunction/worse outcome.	Before surgery and 1 week, 1 month, and 3 months after surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Jing Ding, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): October 15, 2028

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: B2025-473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

IPD (Individual Participant Data) contains individual information of participants (such as demographic characteristics, medical history, examination results, and intervention responses). Even after the "de-identification process", there remains a risk that the participants' identities could be inferred through cross-validation (e.g., by combining regional, age, and disease characteristics).

Compliance with global privacy protection regulations-such as China's Personal Information Protection Law-is required, as these regulations clearly stipulate that "individual sensitive medical data shall not be disclosed unless necessary" to prevent infringement of rights and interests (such as discrimination and identity abuse) caused by privacy leaks.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No