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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Synchron, Inc.
Study ID
NCT07543367
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Single Arm
    Device: Stentrode

Primary Outcome Measure

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

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Megan Donahue
[email protected]
904-953-3647
Huy Tran
[email protected]
904-953-3647
Bjorn Oskarsson, MD (PRINCIPAL_INVESTIGATOR)
University of Buffalo NeurosurgeryBuffaloNew York14203
Ellen Carl
[email protected]
716-218-1000
Elad Levy, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Emily Svendsen
[email protected]
212-241-3238
Shahram Majidi, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15213
Jackie Krugh
Raul Nogueira, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center (UTSW)DallasTexas75390
Tashinga (Tash) Mupambo
Babu Welch, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic· Jacksonville, FLUniversity of Buffalo Neurosurgery· Buffalo, NYMount Sinai Hospital· New York, NYUniversity of Pittsburgh Medical Center (UPMC)· Pittsburgh, PAUniversity of Texas Southwestern Medical Center (UTSW)· Dallas, TX

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