Evaluating a device to help patients with motor disabilities control external equipment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of an implantable neural acquisitor and stimulator system designed for patients with motor disabilities, specifically those with tetraplegia. Utilizing brain-computer interface technology, the system allows patients to control external devices such as wheelchairs and robotic arms using their brain signals. The study will include patients diagnosed with complete or incomplete quadriplegia due to various neurological conditions, ensuring they have a functional brain motor-related cortex. Participants will be monitored for their ability to use the device effectively and safely over the course of the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xuanwu Hospital，Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Huashan Hospital Affiliated to Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Tao Liu, Master
• Email: liutao@neuracle.cn
• Phone: 021-58086056

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Portable control systems to operate a hand motor neuroprosthesis for people with tetraplegia

  The study will test whether several fully portable, non‑invasive control methods (for example shoulder‑motion IMUs, surface EMG, touch/contact sensors, and voice) let adults with tetraplegia reliably control a hand motor neuroprosthesis.

  Recruiting Centre Bouffard Vercelli - USSAP · Perpignan · NCT07058506

• Improving hand function in cervical spinal cord injury with nerve transfers and electrical stimulation

  This study is testing if using electrical stimulation during and after nerve surgery can help people with cervical spinal cord injuries regain hand function and feel less pain.

  Recruiting Stanford University · Palo Alto, California · NCT06541041

• Using a brain-computer interface to help people with tetraplegia communicate

  This study is testing a new brain-computer interface to help people with tetraplegia communicate more easily using a tablet.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06511934

• Nerve transfer surgery to enhance function in high tetraplegia

  This study is testing if nerve transfer surgery can help people with high spinal cord injuries improve their arm function and quality of life.

  Recruiting at 9 sites Washington University School of Medicine · Stanford, California and 9 other locations · NCT06288763

• Using a brain-computer interface to help people with speech difficulties communicate

  This study is testing a brain-computer interface to help people who can't speak due to conditions like ALS communicate by turning their thoughts into speech.

  Recruiting Massachusetts General Hospital · Sacramento, California · NCT06094205

• MindEx multifocal cognitive brain‑machine interface for people with severe paralysis

  This trial will test the MindEx system, which uses four tiny implanted brain chips to let people with severe paralysis control a computer or tablet with their thoughts.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT05936619

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.