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RecruitingNCT07784088LEAPUpdated Aug 25, 2026

Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

An interventional study of IWBCIS in Spinal Cord Injury Cervical, Tetraplegia/Tetraparesis and Spinal Cord Injuries (SCI), sponsored by BCIFlex Medical Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by BCIFlex Medical Technology Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • BCI
  • Tetraplegia
  • Spinal Cord Injuries (SCI)
03

In context

Quadriplegia

222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.

This study's planned enrollment of 34 is above the median of 15 across 193 interventional studies indexed under Quadriplegia.

Browse Quadriplegia studies →

Lead sponsor

This is the only study on the registry with BCIFlex Medical Technology Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, -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; signed by subject or legal representative.

Exclusion criteria

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;
  • -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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Implanted Brain-Computer Interface

    Device: Implantable wireless brain-computer interface systems

    Device: IWBCIS

Interventions

  • DeviceIWBCIS

    Implantable wireless brain-computer interface systems

06

What researchers measure

Primary outcomes

  1. Success rate of brain-controlled tasks

    Time frame: 2, 3, 6 months post-implant

Secondary outcomes

  1. Digital Instrumental Activities of Daily Living (dIADL)

    Time frame: 2, 3, 6 months post-implant

  2. 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.

    Time frame: 2, 3, 6 months post-implant

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, 2, 3, 6 months post-implant

  4. Average Monthly Device Usage Duration

    Time frame: 6 months post-implant

  5. WHO Quality of Life BREF

    Time frame: Baseline, 2, 3, 6 months post-implant

  6. Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)

    Time frame: Baseline, 2, 3, 6 months post-implant

  7. Psychosocial Impact of Assistive Devices Scale (PIADS)

    Time frame: 2, 3, 6 months post-implant

  8. Subject Satisfaction with the Device

    Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device.

    Time frame: 2, 3, 6 months post-implant

  9. Investigator Satisfaction with Device Operation

    Investigator report questionnaire to measure the investigator's satisfaction with device operation.

    Time frame: 2, 3, 6 months post-implant

  10. Device Reliability

    Device Reliability is measure by the Electrode Impedance of the Device

    Time frame: up to 6 months post-implant

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.

Of 97 interventional studies with no phase under Quadriplegia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 309. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 25, 2026
StartActual
Jul 15, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07784088
Lead sponsor
BCIFlex Medical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jul 15, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

BCIFlex
Contact
wangxp@bciflex.com
+86 10 5365 7080

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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