Tetraplegia/TetraparesisCONVOYNCT06710626
Control of Assistive Devices Via Brain-Computer Interface Technology
A study testing Assistive Robotic Arm in people with Tetraplegia/Tetraparesis and Amyotrophic Lateral Sclerosis (ALS), run by Neuralink Corp at 1 site in United States.
Trial summary
The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Quadriplegia
- What is being tested?
- Assistive Robotic Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 25 May 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Continued enrollment in the PRIME Study.
- Implanted with the N1 Implant.
Who cannot join
- Explantation or deactivation of the N1 Implant.
- Insufficient N1 Implant BCI performance demonstrated.
- Lack of a suitable physical space to perform research sessions.
- Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology
The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.
- Conditions
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Quadriplegia, Spinal Cord Injury (SCI), Spinal Cord Injury Cervical
- Being tested
- Assistive Robotic Arm
- Keywords
- brain computer interface, robotic arm, assistive device, Neuralink N1 Implant, Neuralink, N1 Implant, ALS, Spinal cord injury, Quadriplegia, tetraplegia, Robot, external device control, neuroprosthetics
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive Robotic ArmDevice
Also called BCI controlled robotic arm
The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals.
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Not described Receives: Device: Assistive Robotic Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
Measured: 3-months following first use of the assistive device
Secondary outcomes (3)
Rate of Device-Related Adverse Events (AE)
Measured: Up to 72 months after enrollment
Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)
Measured: From enrollment, every 3 months, up to 72 months
Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score
Measured: From enrollment, every 3 months, up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start25 Nov 2024
- Primary completion25 May 2031 (estimated)
- Study completion25 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies 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
- Model description
- The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710626
- Sponsor's protocol ID
- N1-EFS-100
- Acronym
- CONVOY
- Status last verified
- Jun 2025
- First submitted
- 25 Nov 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology
- ClinicalTrials.gov ID
- NCT06710626
- Acronym / sponsor ID
- CONVOY / N1-EFS-100
- Conditions
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Quadriplegia, Spinal Cord Injury (SCI), Spinal Cord Injury Cervical
- Keywords
- brain computer interface, robotic arm, assistive device, Neuralink N1 Implant, Neuralink, N1 Implant, ALS, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Neuralink CorpIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 May 2031 (estimated)
- Study completion
- 25 May 2031 (estimated)
- First posted
- 29 Nov 2024 (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 CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Device: Assistive Robotic Arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Continued enrollment in the PRIME Study.
- Implanted with the N1 Implant.
Key exclusion criteria (4 listed)
- Explantation or deactivation of the N1 Implant.
- Insufficient N1 Implant BCI performance demonstrated.
- Lack of a suitable physical space to perform research sessions.
- Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.
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 |
|---|---|---|
| Assistive Robotic ArmAlso: BCI controlled robotic armThe intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals. | Device | Single |
Primary outcome
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
Time frame: 3-months following first use of the assistive device
3 secondary outcomes
Rate of Device-Related Adverse Events (AE)
Time frame: Up to 72 months after enrollment
Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: From enrollment, every 3 months, up to 72 months
Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score
Time frame: From enrollment, every 3 months, up to 72 months
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 5 Jun 2025.
- Neuralink WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Tetraplegia/Tetraparesis
Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
Recruiting
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
Tetraplegia/Tetraparesis, Rehabilitation Treatment
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
Recruiting
Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Spinal Cord Injury Cervical, Tetraplegia/Tetraparesis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive Robotic Arm in people with Tetraplegia/Tetraparesis and Amyotrophic Lateral Sclerosis (ALS), run by Neuralink Corp at 1 site 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant. (time frame: 3-months following first use of the assistive device). 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 5 Jun 2025.