TetraplegiaNEONCT06990412
A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia
A study testing NEO in people with Tetraplegia and Spinal Cord Injuries (SCI), run by Neuracle Medical Technology(Shanghai) Co.,Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tetraplegia, Spinal Cord Injuries (SCI)
- What is being tested?
- NEO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 28 May 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100053
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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
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.
- Conditions
- Tetraplegia, Spinal Cord Injuries (SCI)
- Being tested
- NEO
- Keywords
- BCI, NEO, Tetraplegia, Spinal cord injury
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEODevice
a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO Receives: Device: NEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCI-assisted ARAT grasp response rate
At 3 months post-operation, the investigator will assess and record the subject's ARAT (Action Research Arm Test) score under BCI-assisted conditions, then compare it with the subject's baseline unassisted ARAT grasp score. The response rate will be calculated as the percentage of responders relative to the total number of participants.
Measured: 3 months post-operation
Adverse Events
Measured: Immediately post-implantation, and at 3-, and 6-months post-operation.
Secondary outcomes (10)
ISNCSCI Score of the Participant
The investigator completes the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) form.
Measured: Baseline, and at 3-, and 6-months post-operation.
ARAT Score for BCI-Assisted Grasping
The investigator completes the ARAT (Action Research Arm Test) scoring form.
Measured: 2-, and 6-months post-operation
ARAT Score
Investigators will complete the ARAT (Action Research Arm Test) Assessment Form.
Measured: Baseline, and at 3-, and 6-months post-operation (assessed with the device powered off).
Investigator's Overall Device Performance Evaluation
Investigators will complete the Investigator's Overall Device Performance Evaluation Form.
Measured: Immediately post-implantation, and at 2-, and 3-, and 6-months post-operation.
Subject's Overall Device Performance Evaluation
Subjects will complete the Subject Device Performance Evaluation Questionnaire.
Measured: 2-, 3-, and 6-months post-operation.
Device Impedance
Record the impedance of each channel; impedance is considered normal if it does not exceed 20 kΩ.
Measured: 1, 2-, 3-, and 6-months post-operation.
Average Monthly Device Usage Time
Calculate the total device usage time per month for each participant.
Measured: 2-, 3-, and 6-months post-operation.
Participant Quality of Life Score
Assessment Method: Participants complete the "Quality of Life Questionnaire"
Measured: Baseline, and at 2-, 3-, and 6-months post-operation.
Subject Satisfaction Rating
Participants evaluate the device's connectivity, operational performance, structural design, and functional design at each follow-up visit.
Measured: 2-, 3-, and 6-months post-operation.
Investigator Satisfaction with Device Operation
At the 1, 2, 3 and 6-month follow-up visits, investigators evaluate the device's connectivity and stability, as well as its electromagnetic compatibility.
Measured: 1-, 2-, 3-, and 6-months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start28 May 2025
- Primary completion6 Nov 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuracle Medical Technology(Shanghai) Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Xuanwu Hospital, Beijing, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Fujian Medical University, Beijing Tiantan Hospital, Henan Provincial People's Hospital, West China Hospital, Affiliated Hospital of Nantong University, The General Hospital of Eastern Theater Command, Peking University Third Hospital, Xiangya Hospital of Central South University, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990412
- Sponsor's protocol ID
- NEURACLE-NEO-202501
- Acronym
- NEO
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06990412
- Acronym / sponsor ID
- NEO / NEURACLE-NEO-202501
- Conditions
- Tetraplegia, Spinal Cord Injuries (SCI)
- Keywords
- BCI, NEO, Tetraplegia, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Neuracle Medical Technology(Shanghai) Co.,Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Xuanwu Hospital, Beijing, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Fujian Medical University, Beijing Tiantan Hospital, Henan Provincial People's Hospital, West China Hospital, Affiliated Hospital of Nantong University, The General Hospital of Eastern Theater Command, Peking University Third Hospital, Xiangya Hospital of Central South University, Tongji Hospital
- Study start
- 28 May 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: NEOa Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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."
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEOa Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO | Device | Treatment group |
Primary outcome
BCI-assisted ARAT grasp response rate
Time frame: 3 months post-operation
At 3 months post-operation, the investigator will assess and record the subject's ARAT (Action Research Arm Test) score under BCI-assisted conditions, then compare it with the subject's baseline unassisted ARAT grasp score. The response rate will be calculated as the percentage of responders relative to the total number of participants.
Adverse Events
Time frame: Immediately post-implantation, and at 3-, and 6-months post-operation.
10 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEO in people with Tetraplegia and Spinal Cord Injuries (SCI), run by Neuracle Medical Technology(Shanghai) Co.,Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCI-assisted ARAT grasp response rate (time frame: 3 months post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.