Amyotrophic Lateral SclerosisCONNECT-ONENCT07357428
Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)
A study testing Connexus Brain-Computer Interface in people with Amyotrophic Lateral Sclerosis and Neuromuscular Disease, run by Paradromics at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neuromuscular Disease, Stroke
- What is being tested?
- Connexus Brain-Computer Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2026to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Matthew Willsey, M.D,. P.h.D
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Daniel Rubin, M.D., Ph.D.
- Recruiting
University of California, Davis
Sacramento, California, 95817
David Brandman M.D., Ph.D.
About this study
Official title: Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
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
- Being tested
- Connexus Brain-Computer Interface
- Keywords
- BCI, ALS, Paradromics, speech, dysarthria, neural injury, progressive neuromuscular disease, stroke, assistive technology, communication device, brain computer interface
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Stroke, Quadriplegia, Dysarthria, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connexus Brain-Computer InterfaceDevice
The Connexus Brain Computer Interface is an implantable brain-computer interface.
| Study group | Role | What they receive |
|---|---|---|
| Connect-One | Other | Not described Receives: Device: Connexus Brain-Computer Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: Number of Subjects With Device Related Adverse Events
Device Related Adverse Events: Number of subjects with device-related adverse events
Measured: 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
Measured: Up to 6 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start31 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paradromics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan, University of California, Davis, Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357428
- Sponsor's protocol ID
- PRT-1014
- Acronym
- CONNECT-ONE
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) to Provide Human Connection Through Communication
- ClinicalTrials.gov ID
- NCT07357428
- Acronym / sponsor ID
- CONNECT-ONE / PRT-1014
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- ParadromicsIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan, University of California, Davis, Massachusetts General Hospital
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Connect-One | Other | Device: Connexus Brain-Computer Interface |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connexus Brain-Computer InterfaceThe Connexus Brain Computer Interface is an implantable brain-computer interface. | Device | Connect-One |
Primary outcome
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
1 secondary outcome
Long-Term Safety: Number of Subjects With Device Related Adverse Events
Time frame: Up to 6 years post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Paradromics Clinical StudyLink provided by the sponsor.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Active, not recruitingObservational study
PREVENT ALL ALS Study
Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
RecruitingObservational study
Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis
Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Regulatory T Cells for Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connexus Brain-Computer Interface in people with Amyotrophic Lateral Sclerosis and Neuromuscular Disease, run by Paradromics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paradromics Clinical Team ((512) 559 4120, clinical-team@paradromics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety: Number of Subjects With Device Related Adverse Events (time frame: Up to 12 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.