TetraplegiaNCT05920174
Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
A study testing NEO in people with Tetraplegia, run by Neuracle Medical Technology(Shanghai) Co.,Ltd. at 4 sites in China.
Trial summary
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- NEO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesChina
- Study dates
- 17 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years of age;
- Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
- After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
- The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
- The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
Who cannot join
- Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
- Combined with progressive neurological disease；
- Combined with surgical contraindications identified by surgeons and anesthesiologists;
- Participating in other clinical trials;
- Other conditions deemed inappropriate by investigators and medical staff.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Xinguang Yu, Ph.D
Xinguang Yu, Ph.D
- Recruiting
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100053
Guoguang Zhao, Ph.D
Guoguang Zhao, Ph.D
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Wang Jia, Ph.D
Wang Jia, Ph.D
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Liang Chen, Ph.D
Liang Chen
About this study
Official title: A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
Read the detailed description
To evaluate the safety and efficacy of an implantable neural acquisitor \& stimulator system in patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
- Conditions
- Tetraplegia
- Being tested
- NEO
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEODevice
Subjects will be implanted with the NEO device.
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | Patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).
Implantation of NEO device. Receives: Device: NEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Participants With the device-Related Adverse Events
Measured: 12 months after implantation
Secondary outcomes (4)
BCI performance classification accuracy
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by classification accuracy (percentage of patient correct commands to overall number of detected commands)
Measured: 3, 6, 12 months after implantation
BCI performance by bit rate
Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by bit rate (number of commands per minute).
Measured: 3, 6, 12 months after implantation
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Hours use of the implantable neural acquisitor \& stimulator (NEO) per month
Measured: 3, 6, 12 months after implantation
Patient/caregiver satisfaction
The evaluation of patient and caregiver satisfaction will be carried out using a "satisfaction questionnaire" designed by the researcher (rated from Level 1 to 5) on their feelings (patient/caregiver) of use.
Measured: 3, 6, 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start17 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
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
- an implantable neural acquisitor \& stimulator system
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuracle Medical Technology(Shanghai) Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Chinese PLA General Hospital, Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920174
- Sponsor's protocol ID
- FABRK202301
- Status last verified
- Dec 2024
- First submitted
- 29 May 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
- ClinicalTrials.gov ID
- NCT05920174
- Acronym / sponsor ID
- FABRK202301
- Conditions
- Tetraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Neuracle Medical Technology(Shanghai) Co.,Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Chinese PLA General Hospital, Huashan Hospital
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2023 (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.
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
Detailed description
To evaluate the safety and efficacy of an implantable neural acquisitor \& stimulator system in patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients 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
- an implantable neural acquisitor \& stimulator system
| Arm | Type | Receives |
|---|---|---|
| single | Experimental | Device: NEOPatients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders). Implantation of NEO device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 80 years of age;
- Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
- After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
- The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
- The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
Key exclusion criteria (5 listed)
- Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
- Combined with progressive neurological disease；
- Combined with surgical contraindications identified by surgeons and anesthesiologists;
- Participating in other clinical trials;
- Other conditions deemed inappropriate by investigators and medical staff.
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 |
|---|---|---|
| NEOSubjects will be implanted with the NEO device. | Device | single |
Primary outcome
Adverse Events
Time frame: 12 months after implantation
Number of Participants With the device-Related Adverse Events
4 secondary outcomes
BCI performance classification accuracy
Time frame: 3, 6, 12 months after implantation
BCI performance by bit rate
Time frame: 3, 6, 12 months after implantation
Hours use of the implantable neural acquisitor & stimulator (NEO) per month
Time frame: 3, 6, 12 months after implantation
Patient/caregiver satisfaction
Time frame: 3, 6, 12 months after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- 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.
4 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, run by Neuracle Medical Technology(Shanghai) Co.,Ltd. at 4 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Liu, Master (021-58086056, liutao@neuracle.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months after implantation). 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 5 Dec 2024.