Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

NCT07784088 | Recruiting

• 1 other identifier: ZR202601
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury Cervical; Tetraplegia/Tetraparesis; Spinal Cord Injuries (SCI)

Keywords

BCI; Tetraplegia; Spinal Cord Injuries (SCI)

Outcome Measures

Primary Outcomes (1)

• Success rate of brain-controlled tasks

  2, 3, 6 months post-implant

Secondary Outcomes (10)

• Digital Instrumental Activities of Daily Living (dIADL)

  2, 3, 6 months post-implant

• Brain Control Fluency Index

  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

Study Arms (1)

Implanted Brain-Computer Interface

EXPERIMENTAL

Device: Implantable wireless brain-computer interface systems

Device: IWBCIS

Interventions

IWBCIS DEVICE

Implantable wireless brain-computer interface systems

Implanted Brain-Computer Interface

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BCIFlex Medical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

BCIFlex

CONTACT

+86 10 5365 7080; wangxp@bciflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 25, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

CN (1)