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NCT Number: NCT05920174

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NEO

Device

Subjects will be implanted with the NEO device.

Primary outcomes

  1. Adverse Events

    Time frame: 12 months after implantation

    Number of Participants With the device-Related Adverse Events

Secondary outcomes

  1. BCI performance classification accuracy

    Time frame: 3, 6, 12 months after implantation

    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)

  2. BCI performance by bit rate

    Time frame: 3, 6, 12 months after implantation

    Achieved performance on BCI at conclusion of BCI sessions for each subject. Measured by bit rate (number of commands per minute).

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

    Time frame: 3, 6, 12 months after implantation

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

  4. Patient/caregiver satisfaction

    Time frame: 3, 6, 12 months after implantation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Liu, Master

CONTACT

[email protected]

021-58086056

Sponsors and collaborators

Lead sponsor

Neuracle Medical Technology(Shanghai) Co.,Ltd.

Industry

Collaborators

  • Beijing Tiantan Hospital
  • Chinese PLA General Hospital
  • Huashan Hospital
  • Xuanwu Hospital, Beijing

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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