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

NCT05920174 | Recruiting

• 1 other identifier: FABRK202301
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of Participants With the device-Related Adverse Events

  12 months after implantation

Secondary Outcomes (4)

• BCI performance classification accuracy

  3, 6, 12 months after implantation

• BCI performance by bit rate

  3, 6, 12 months after implantation

• Hours use of the implantable neural acquisitor & stimulator (NEO) per month

  3, 6, 12 months after implantation

• Patient/caregiver satisfaction

  3, 6, 12 months after implantation

Study Arms (1)

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.

Device: NEO

Interventions

NEO DEVICE

Subjects will be implanted with the NEO device.

single

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuracle Medical Technology(Shanghai) Co.,Ltd.: lead
• Xuanwu Hospital, Beijing: collaborator
• Beijing Tiantan Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (4)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

NOT YET RECRUITING

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tao Liu, Master

CONTACT

021-58086056; liutao@neuracle.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: an implantable neural acquisitor \& stimulator system

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 27, 2023
• Study Start: October 17, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)