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

NCT07357428 | Recruiting DMC FDA Device

• 1 other identifier: PRT-1014
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Disease; Stroke; Tetraplegia/Tetraparesis; Cervical Spinal Cord Injury; Dysarthria

Keywords

BCI; ALS; Paradromics; speech; dysarthria; neural injury; progressive neuromuscular disease; stroke; assistive technology; communication device; brain computer interface

Outcome Measures

Primary Outcomes (1)

• Primary Safety: Number of Subjects With Device Related Adverse Events

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

  Up to 12 months post-implant

Secondary Outcomes (1)

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

  Up to 6 years post-implant

Study Arms (1)

Connect-One

OTHER

Device: Connexus Brain-Computer Interface

Interventions

Connexus Brain-Computer Interface DEVICE

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

Connect-One

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paradromics: lead
• University of Michigan: collaborator
• University of California, Davis: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Links

• Paradromics Clinical Study

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases; Stroke; Quadriplegia; Dysarthria; Speech

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Verbal Behavior; Communication; Behavior

Central Study Contacts

Paradromics Clinical Team

CONTACT

(512) 559 4120; clinical-team@paradromics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 22, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (3)