Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Tetraplegia Clinical Trial

Official title:

A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05920174
• Other study ID #: FABRK202301
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Neuracle Medical Technology(Shanghai) Co.,Ltd.
• Contact: Tao Liu, Master
• Phone: 021-58086056
• Email: liutao[@]neuracle.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 80 years of age;

2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;

3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease;

4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment;

5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.

Exclusion Criteria:

1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses;

2. Combined with progressive neurological disease;

3. Combined with surgical contraindications identified by surgeons and anesthesiologists;

4. Participating in other clinical trials;

5. Other conditions deemed inappropriate by investigators and medical staff.

Related Conditions & MeSH terms

• Quadriplegia
• Tetraplegia

Intervention

Device:
• NEO
Subjects will be implanted with the NEO device.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Xuanwu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Neuracle Medical Technology(Shanghai) Co.,Ltd.	Beijing Tiantan Hospital, Chinese PLA General Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of Participants With the device-Related Adverse Events	12 months after implantation
Secondary	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)	3, 6, 12 months after implantation
Secondary	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).	3, 6, 12 months after implantation
Secondary	Hours use of the implantable neural acquisitor & stimulator (NEO) per month	Hours use of the implantable neural acquisitor & stimulator (NEO) per month	3, 6, 12 months after implantation
Secondary	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.	3, 6, 12 months after implantation