MedTrace Logo

[BrainConnexion] - Neurodevice Phase I Trial

NCT03811301 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-05-06

No results posted yet for this study

Summary

This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.

Conditions

  • Tetraplegia
  • Tetraplegia/Tetraparesis
  • Spinal Cord Injuries
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
  • Locked-in Syndrome
  • Muscular Dystrophies

Interventions

DEVICE

BrainConnexion

A 4.4mm by 4.2mm electrode array is placed onto the surface of the motor cortex which is then connected to a miniaturized neural recording microsystem that transmits signals wirelessly to control an external assistive device. Neural signals are recorded at least once every week for 12 months or longer.

Sponsors & Collaborators

  • Institute of Microelectronics

    collaborator UNKNOWN

  • Institute of Molecular and Cell Biology

    collaborator UNKNOWN

  • Institute for Infocomm Research

    collaborator OTHER

  • Nanyang Technological University

    collaborator OTHER

  • National Neuroscience Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2023-01-27
Completion
2023-08-27
FDA Device
Yes

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811301 on ClinicalTrials.gov