NCT05920174

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Neuracle Medical Technology(Shanghai) Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tetraplegia

Interventions

Type	Name	Description
DEVICE	NEO	Subjects will be implanted with the NEO device.

Timeline

• Start date: 2023-10-17
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-06-27
• Last updated: 2024-12-05

Locations

4 sites across 1 country: China