Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia (LEAP)

A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.

Study Overview

• Status: Recruiting
• Conditions: Tetraplegia/Tetraparesis; Spinal Cord Injury Cervical; Spinal Cord Injuries (SCI)
• Intervention / Treatment: Device: IWBCIS

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BCIFlex; Phone Number: +86 10 5365 7080; Email: wangxp@bciflex.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Wang Jia, MD; Phone Number: +86 10 5997 6512; Email: jwttyy@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥18 years and ≤65 years, male or female;
• Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;
• Intact cognitive function, MoCA-BLIND score ≥19;
• Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;
• Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;
• Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment;
• Good compliance, voluntary participation; informed consent signed by subject or legal representative.

Exclusion Criteria:

• Syringomyelia, severe neuralgia or spasticity limiting training participation;
• Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
• High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
• Subjects implanted with CNS electrical stimulation medical devices;
• Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment;
• Severe, unstable, uncontrolled complex regional pain syndrome;
• Autoimmune-induced spinal cord dysfunction/injury;
• History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease;
• Peripheral neuropathy;
• Pregnant/breastfeeding females, females planning pregnancy during trial;
• Require MRI examinations during device implantation period;
• Participated in other clinical trials within 1 month prior to enrollment;
• Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.

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: Implanted Brain-Computer Interface; Device: Implantable wireless brain-computer interface systems	Device: IWBCIS; Implantable wireless brain-computer interface systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of brain-controlled tasks	2, 3, 6 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital Instrumental Activities of Daily Living (dIADL)		2, 3, 6 months post-implant
Brain Control Fluency Index	The Brain Control Fluency Index is defined as the mean Information Transfer Rate measured by the Web-Grid Task performed by the patients with implantable wireless Brain-Computer Interface System.	2, 3, 6 months post-implant
Patient Health Questionnaire-9 (PHQ-9)		Baseline, 2, 3, 6 months post-implant
Average Monthly Device Usage Duration		6 months post-implant
WHO Quality of Life BREF		Baseline, 2, 3, 6 months post-implant
Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)		Baseline, 2, 3, 6 months post-implant
Psychosocial Impact of Assistive Devices Scale (PIADS)		2, 3, 6 months post-implant
Subject Satisfaction with the Device	Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device.	2, 3, 6 months post-implant
Investigator Satisfaction with Device Operation	Investigator report questionnaire to measure the investigator's satisfaction with device operation.	2, 3, 6 months post-implant
Device Reliability	Device Reliability is measure by the Electrode Impedance of the Device	up to 6 months post-implant

Collaborators and Investigators

• Sponsor: BCIFlex Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Tetraplegia; Spinal Cord Injuries (SCI); BCI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: ZR202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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