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

April 22, 2026 updated by: Shanghai Zhongshan Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Grasping Success Rate
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grasping Object Type Coverage
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
The correctness of converting electroencephalographic (EEG) signals into grasping commands
Before surgery and 1 week, 1 month, and 3 months after surgery
Grasping Latency
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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)
Time Frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jing Ding, PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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