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RecruitingNCT07357428CONNECT-ONEUpdated Apr 14, 2026

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

An interventional study of Connexus Brain-Computer Interface in Amyotrophic Lateral Sclerosis, Neuromuscular Disease and Stroke, sponsored by Paradromics. Recruiting at 3 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Paradromics · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
22 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • 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
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In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's planned enrollment of 2 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

This is the only study on the registry with Paradromics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (estimated)

Study arms

  • Other
    Connect-One

    Device: Connexus Brain-Computer Interface

Interventions

  • DeviceConnexus Brain-Computer Interface

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

06

What researchers measure

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

    Time frame: Up to 12 months post-implant

Secondary outcomes

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

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

    Time frame: Up to 6 years post-implant

07

Study locations

3 of 3 sites recruiting
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References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for May 2027, 14 months after the start.

Of 154 interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2025
First posted
Jan 22, 2026
StartActual
Mar 31, 2026
Primary completionEst.
May 2027
CompletionEst.
Jan 2032
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07357428
Lead sponsor
Paradromics
Collaborators
University of Michigan, University of California, Davis, Massachusetts General Hospital
Responsible party
Sponsor
First posted
Jan 22, 2026
Start date
Mar 31, 2026
Primary completion
May 2027 (estimated)
Completion
Jan 2032 (estimated)
Last update
Apr 14, 2026

Study contacts

Paradromics Clinical Team
Contact
clinical-team@paradromics.com
(512) 559 4120

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

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