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

NCT07543367 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: S-03-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Neurological Disorder; Motor Neuron Disease; ALS; ALS - Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  6 Months

Secondary Outcomes (3)

• Device-related serious adverse events up to 1 year after implant

  12 Months

• Target vessel patency assessed using CT venography at 180 days and 364 days after implant

  6 Months and 12 Months

• Device migration assessed using CT images at 180 days and 365 days after implant

  6 Months and 12 Months

Other Outcomes (4)

• Time in days from implant to device activation

  Number of days from device implant to device activation, up to 12 months after implant

• Time in days from device activation to successful demonstration of motor signal transmission.

  Number of days from device activation to successful demonstration of motor signal transmission, up to 12 months after implant.

• Stability of recorded Synchron BCI signal up to 3 years after device implant

  12 Months

Study Arms (1)

Single Arm

OTHER

Device: Stentrode

Device: Stentrode

Interventions

Stentrode DEVICE

The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

Single Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synchron, Inc.: lead

Study Sites (4)

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern Medical Center (UTSW)

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Nervous System Diseases; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Insertion of Stentrode Device

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)