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Not yet recruiting NCT06990412

A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

No phase Interventional Tetraplegia Spinal Cord Injuries (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NEO.
Who it may be relevant to
Registry conditions: Tetraplegia, Spinal Cord Injuries (SCI). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

Overview

To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration. Through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.

Interventions

  • Device NEO
    a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

Primary outcome measures

  • BCI-assisted ARAT grasp response rate [Time frame: 3 months post-operation]
  • Adverse Events [Time frame: Immediately post-implantation, and at 3-, and 6-months post-operation.]
Secondary outcome measures (10)
  • ISNCSCI Score of the Participant [Time frame: Baseline, and at 3-, and 6-months post-operation.]
  • ARAT Score for BCI-Assisted Grasping [Time frame: 2-, and 6-months post-operation]
  • ARAT Score [Time frame: Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).]
  • Investigator's Overall Device Performance Evaluation [Time frame: Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.]
  • Subject's Overall Device Performance Evaluation [Time frame: 2-, 3-, and 6-months post-operation.]
  • Device Impedance [Time frame: 1, 2-, 3-, and 6-months post-operation.]
  • Average Monthly Device Usage Time [Time frame: 2-, 3-, and 6-months post-operation.]
  • Participant Quality of Life Score [Time frame: Baseline, and at 2-, 3-, and 6-months post-operation.]
  • Subject Satisfaction Rating [Time frame: 2-, 3-, and 6-months post-operation.]
  • Investigator Satisfaction with Device Operation [Time frame: 1-, 2-, 3-, and 6-months post-operation.]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years old, no restriction on gender.
  • Tetraplegia caused by cervical spinal cord injury.
  • Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test).
  • Muscle strength of finger flexors < grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury).
  • 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."
  • Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified.
  • Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment.
  • Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial.

Exclusion criteria

  • Without the consent of the patient or the patient's legal guardian.
  • Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training.
  • Requires ventilator support.
  • Baclofen dosage >30 mg/day.
  • 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.
  • High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000.
  • Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system.
  • 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.
  • Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome.
  • Autoimmune-mediated spinal cord dysfunction/injury.
  • History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy.
  • Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies).
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 2 centers
  • Xuanwu Hospital，Capital Medical University — Beijing
  • Huashan Hospital Affiliated to Fudan University — Shanghai

Identifiers

NCT: NCT06990412 · NEURACLE-NEO-202501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗