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INTENT Study: Stentrode for Neurological Disorders like ALS

This study, called INTENT, is testing a device called Stentrode. The Stentrode is a small implant that goes into a blood vessel in your brain. It's designed to pick up brain signals and help people with conditions like ALS (Amyotrophic Lateral Sclerosis) control digital devices, especially if they have weakness in both arms. To join, you must have ALS that has not responded to other treatments for at least six months, be 22 or older, and have a life expectancy of more than 12 months. The main goal is to see if the Stentrode causes any serious problems within 180 days (about 6 months) after it's implanted. The study plans to enroll 10 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for device-related serious adverse events for up to 180 days (6 months) after the implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07543367

INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study

Recruiting
NAAges 22+Interventional
Synchron, Inc.
~10 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Stentrode

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device-related serious adverse events up to 180 days after implant
Measured over 6 Months

Conditions

Neurological Disorder
ALS (Amyotrophic Lateral Sclerosis)
Motor Neuron Disease
ALS - Amyotrophic Lateral Sclerosis
ALS

Explore related trials

Amyotrophic Lateral Sclerosis

NCT07543367

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Mount Sinai Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

  • University of Buffalo Neurosurgery

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvaniano site contact published

    Not yet recruiting

  • University of Texas Southwestern Medical Center (UTSW)

    Dallas, Texasno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Megan Donahue
[email protected]
904-953-3647
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Device-related serious adverse events up to 180 days after implant6 Months