Mind over matter: can a brain implant restore hand control?
NCT ID NCT06990412
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) called NEO in people with tetraplegia caused by cervical spinal cord injury. The device is designed to let participants control external equipment using their brain signals, potentially improving their ability to perform everyday tasks. The study will measure safety and whether the BCI helps with grasping actions, comparing performance with and without the device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an implantable wireless brain-computer interface system called NEO
- What this could lead to
- If successful, this could offer a new way for people with tetraplegia to control external devices—like computers or assistive tools—using only 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, so results may not apply broadly. Implanting a device in the brain carries risks such as infection, bleeding, or device malfunction, and the technology may not work as hoped.
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
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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
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32 people
The number who actually took part.
- Started
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May 2025
- Finished
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Jan 2026
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age between 18 and 65 years old, no restriction on gender. 2. Tetraplegia caused by cervical spinal cord injury. 3. Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test). 4. Muscle strength of finger flexors \< grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury). 5. Score of ≥2 for "hand to mouth" on ARAT; scores of ≥1 for both "hand to top of head" and "hand to behind the head." 6. Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified. 7. Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment. 8. Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial. Exclusion Criteria: 1. Without the consent of the patient or the patient's legal guardian. 2. Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training. 3. Requires ventilator support. 4. Baclofen dosage \>30 mg/day. 5. Received botulinum toxin injections in the upper limb, neck, or hand within 6 months prior to enrollment, or received stem cell therapy within 1 year. 6. High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000. 7. Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system. 8. Any unstable or significant medical condition that may interfere with study procedures or confound the evaluation of study endpoints, such as depression, mood disorders, or other cognitive impairments. 9. Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome. 10. Autoimmune-mediated spinal cord dysfunction/injury. 11. History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy. 12. Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies). 13. In the investigator's opinion, the study is unsafe or inappropriate for the participant, or the participant is unlikely to comply with the study follow-up schedule.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
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Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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