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NCT Number: NCT07357428

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

The Connect-One Study is an early feasibility study to obtain preliminary device safety information for the Connexus Brain-Computer Interface (BCI). The Connexus BCI is intended to be used as: (1) an assistive communication device to decode imagined language correlates and speech for patients with impaired communication as a result of severe loss of voluntary motor control; and (2) to provide control of computer devices for individuals with severe loss of voluntary motor control of the upper extremity.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Articulation Disorders Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Communication Communication Disorders Dysarthria Language Disorders Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Disease Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Signs and Symptoms Speech Speech Disorders Spinal Cord Diseases Stroke TDP-43 Proteinopathies Tetraplegia/Tetraparesis Vascular Diseases Verbal Behavior

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of a progressive neuromuscular disease or a neurological injury.
  • Clinical diagnosis of anarthria or severe dysarthria.
  • Wheelchair dependent with severely impaired upper limb function.
  • Has a reliable method of communication and the ability to read and understand the English language.
  • Has a study care partner (e.g. caregiver or multiple caregivers) for the duration of the study.
  • Lives within a 4-hour radius of a study site.

Exclusion criteria

  • Cognitive impairment or psychiatric illness that could impact the ability to comply with study requirements, as determined by the Study Investigator.
  • Co-morbidities or an ongoing chronic medical condition that would impair the ability to comply with study requirements.
  • The presence of another implanted device, like a pacemaker, deep brain stimulator, or implantable pulse generator.
  • Requires, or is expected to require regular MRI scans for on-going medical conditions.
  • In the opinion of the Study Investigator, the patient is not an appropriate candidate for the study, for reasons that could place the patient at undue risk or otherwise result in non-compliance with the study requirements.

Treatment and study plan

Connexus Brain-Computer Interface

Device

The Connexus Brain Computer Interface is an implantable brain-computer interface.

Primary outcomes

  1. Primary Safety: Number of Subjects With Device Related Adverse Events

    Time frame: Up to 12 months post-implant

    Device Related Adverse Events: Number of subjects with device-related adverse events

Secondary outcomes

  1. Long-Term Safety: Number of Subjects With Device Related Adverse Events

    Time frame: Up to 6 years post-implant

    Device Related Adverse Events: Number of subjects with device-related adverse events

Study contacts

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

Paradromics Clinical Team

CONTACT

[email protected]

(512) 559 4120

Sponsors and collaborators

Lead sponsor

Paradromics

Industry

Collaborators

  • Massachusetts General Hospital
  • University of California, Davis
  • University of Michigan

Registry information

Official study title

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication

Acronym: CONNECT-ONE

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Jan 22, 2026
Registry last updated
Apr 14, 2026

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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