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

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.

Study Overview

• Status: Recruiting
• Conditions: Tetraplegia
• Intervention / Treatment: Device: NEO

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 Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Liu, Master; Phone Number: 021-58086056; Email: liutao@neuracle.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Wang Jia, Ph.D
      • Principal Investigator: Wang Jia, Ph.D
    • Beijing, Beijing, China, 100039
      • Not yet recruiting
      • Chinese PLA General Hospital
      • Contact: Xinguang Yu, Ph.D
      • Principal Investigator: Xinguang Yu, Ph.D
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital,Capital Medical University
      • Contact: Guoguang Zhao, Ph.D
      • Principal Investigator: Guoguang Zhao, Ph.D
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital Affiliated to Fudan University
      • Principal Investigator: Liang Chen
      • Contact: Liang Chen, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single; 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; Subjects will be implanted with the NEO device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of Participants With the device-Related Adverse Events	12 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paralysis; Quadriplegia
• Other Study ID Numbers: FABRK202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No