Reanimation in Tetraplegia

Marcia Bockbrader

Status

Completed

Conditions

Spinal Cord Injury (Quadraplegia)

Treatments

Device: Neural Bridge System

Study type

Interventional

Funder types

Other

Identifiers

NCT01997125

2013H0164 (Other Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.

Full description

This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.

Enrollment

1 patient

Sex

All

Ages

21 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be 21 years or older.
Must be tetraplegic (C4- C6 ASIA A).
12 months post injury and neurologically stable.
Participant is willing to comply with all follow-up evaluations at the specified times.
Participant is able to provide informed consent prior to enrollment in the study.
The participant is fluent in English.
Participant must have a caregiver willing to participate in the study who will provide care for the surgical site.

Exclusion criteria

No active wound healing or skin breakdown issues.
No history of poorly controlled autonomic dysreflexia.
Medical contraindications for general anesthesia, craniotomy, or surgery.
Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI.
History of psychiatric disturbance or dementia
Other implantable devices such as heart/brain pacemakers
Participants who rely on ventilators
Co-morbid conditions that would interfere with study activities or response to treatment.
History of a neurological ablation procedure.
Labeled contraindication for MRI.
History of hemorrhagic stroke.
History of HIV infection or ongoing chronic infection (such as tuberculosis).
Pregnant or of child-bearing potential and are not taking acceptable methods of contraception.
Participation in another FDA device or medication trial that would interfere with the current study.