Neurological DisorderNCT07543367
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
A study testing Stentrode in people with Neurological Disorder and ALS (Amyotrophic Lateral Sclerosis), run by Synchron, Inc. at 5 sites in United States.
Trial summary
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis), Motor Neuron Disease
- What is being tested?
- Stentrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2026to Dec 2029
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent to participate in the study.
- Diagnosis of ALS, with bilateral upper-limb paresis.
- ALS must be refractory to treatment and have been present for a minimum of six months.
- Aged 22 years or older.
- Life expectancy greater than 12 months post-implantation.
- Preserved precentral gyrus assessed using CT.
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- Suitable vascular anatomy assessed using CT venography.
- Suitable anatomy for subcutaneous pocket creation.
- Able to undergo anesthesia.
- Willing and able to comply with all investigational requirements, including clinical testing visits and training visits in the home.
- Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging).
- Patient and caregiver fluent in English.
- Suitable home environment for BCI training.
Who cannot join
- Active infection or unexplained fever in the 48 hours prior to informed consent.
- Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
- Diagnosis of ALS-FTD or another dementia.
- Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).
- Known allergy to patient-contacting materials included in the implanted device.
- Contraindication to angiographic imaging or iodine contrast media.
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- History of central venous sinus thrombosis.
- Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state.
- Contraindication to antithrombotic therapy.
- Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.
- Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.
- Pregnant or breast feeding.
- Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.
- Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Buffalo Neurosurgery
Buffalo, New York, 14203
Ellen Carl, 716-218-1000, ecarl@ubns.com
Elad Levy, MD
- Not yet recruiting
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, 75390
Tashinga (Tash) Mupambo
Babu Welch, MD
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Megan Donahue, 904-953-3647, donahue.megan@mayo.edu
Huy Tran, 904-953-3647, tran.huy1@mayo.edu
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Emily Svendsen, 212-241-3238, emily.svendsen@mountsinai.org
Shahram Majidi, MD
- Not yet recruiting
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Jackie Krugh
Raul Nogueira, MD
About this study
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Read the detailed description
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for individuals with bilateral upper-limb motor impairment, such as Amyotrophic Lateral Sclerosis (ALS). The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.
- Conditions
- Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis), Motor Neuron Disease, ALS - Amyotrophic Lateral Sclerosis, ALS
- Being tested
- Stentrode
- Medical subject headings
- Nervous System Diseases, Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentrodeDevice
The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Device: Stentrode Receives: Device: Stentrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related serious adverse events up to 180 days after implant
Measured: 6 Months
Secondary outcomes (3)
Device-related serious adverse events up to 1 year after implant
Measured: 12 Months
Target vessel patency assessed using CT venography at 180 days and 364 days after implant
Measured: 6 Months and 12 Months
Device migration assessed using CT images at 180 days and 365 days after implant
Measured: 6 Months and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start7 May 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies 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
- Insertion of Stentrode Device
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synchron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543367
- Sponsor's protocol ID
- S-03-02
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans at this time.