Recruiting

Neuroprosthetic Technology

Sponsor:

Synchron, Inc.

Code:

NCT07543367

Conditions

Neurological Disorder

ALS (Amyotrophic Lateral Sclerosis)

Motor Neuron Disease

ALS - Amyotrophic Lateral Sclerosis

ALS

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Stentrode

Study Details

Brief summary:

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

Conditions

Neurological Disorder

ALS (Amyotrophic Lateral Sclerosis)

Motor Neuron Disease

ALS - Amyotrophic Lateral Sclerosis

ALS

Study ID

NCT07543367

Start date

Apr, 2026

Status verified date

May, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Single Arm

Device: Stentrode

Interventions

Stentrode

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

Primary outcome measure

  • Device-related serious adverse events up to 180 days after implant [ Time Frame: 6 Months ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Megan Donahue

904-953-3647donahue.megan@mayo.edu

Huy Tran

904-953-3647tran.huy1@mayo.edu

Principal Investigator:

Bjorn Oskarsson, MD

University of Buffalo Neurosurgery

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ellen Carl

716-218-1000ecarl@ubns.com

Principal Investigator:

Elad Levy, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Emily Svendsen

212-241-3238emily.svendsen@mountsinai.org

Principal Investigator:

Shahram Majidi, MD

More Information

Sponsor

Synchron, Inc.

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Synchron, Inc. on 2026-05-11.