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Mind over matter: can a wireless brain implant restore control for the paralyzed?

NCT ID NCT07784088

Disease control Sponsor: BCIFlex Medical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial is testing an implantable wireless brain-computer interface (BCI) in people with tetraplegia caused by cervical spinal cord injury. The device is designed to read brain signals and translate them into commands to control external devices, such as a computer cursor or assistive tools. The study will evaluate how safe the implant is and how well participants can perform brain-controlled tasks. If it works, this technology could offer a new way for people with severe paralysis to interact with their environment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implantable wireless brain-computer interface system
What this could lead to
If successful, this could offer a way for people with severe paralysis to control assistive devices using their thoughts, potentially improving independence and quality of life.
What could go wrong
This is an early-stage trial with a small number of participants. The device requires brain surgery, which carries risks like infection or bleeding, and it may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

quadriplegia spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries (SCI) Spinal cord injury cervical Tetraplegia/tetraparesis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, China

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