Reanimation in Tetraplegia

Completed · Not applicable

Conditions studied: Spinal Cord Injury (Quadraplegia)

In brief

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.

Key facts

Study ID

NCT01997125

Run by

Marcia Bockbrader

People needed

1

Starts

2013-11-01

Expected to finish

2019-06-13

Last updated by the study team

2021-08-31

Who can join

Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Ohio State University Wexner Medical Center - Center for Neuromodulation — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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