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

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

Study Overview

• Status: Recruiting
• Conditions: ALS (Amyotrophic Lateral Sclerosis); Motor Neuron Disease; ALS; Neurological Disorder; ALS - Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: Stentrode

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Megan Donahue; Phone Number: 904-953-3647; Email: donahue.megan@mayo.edu
      • Principal Investigator: Bjorn Oskarsson, MD
      • Contact: Huy Tran; Phone Number: 904-953-3647; Email: tran.huy1@mayo.edu
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University of Buffalo Neurosurgery
      • Principal Investigator: Elad Levy, MD
      • Contact: Ellen Carl; Phone Number: 716-218-1000; Email: ecarl@ubns.com
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Shahram Majidi, MD
      • Contact: Emily Svendsen; Phone Number: 212-241-3238; Email: emily.svendsen@mountsinai.org
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Not yet recruiting
      • University of Pittsburgh Medical Center (UPMC)
      • Principal Investigator: Raul Nogueira, MD
      • Contact: Jackie Krugh
  • Texas
    • Dallas, Texas, United States, 75390
      • Not yet recruiting
      • University of Texas Southwestern Medical Center (UTSW)
      • Principal Investigator: Babu Welch, MD
      • Contact: Tashinga (Tash) Mupambo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Device: Stentrode	Device: Stentrode; The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device-related serious adverse events up to 180 days after implant	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Synchron BCI use up to 1 year after device implant	12 Months

Collaborators and Investigators

• Sponsor: Synchron, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Nutritional and Metabolic Diseases; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Nervous System Diseases
• Other Study ID Numbers: S-03-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes