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Reanimation in Tetraplegia

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ClinicalTrials.gov Identifier: NCT01997125
Recruitment Status : Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Marcia Bockbrader, Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury (Quadraplegia) Device: Neural Bridge System Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reanimation in Tetraplegia
Actual Study Start Date : November 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Open Label
Neural bridge system implant and external stimulator
Device: Neural Bridge System
Implanted device
Other Names:
  • Blackrock Microsystems Neuroport
  • Neuromuscular Stimulator




Primary Outcome Measures :
  1. Voluntary Movement [ Time Frame: 9 months ]
    The primary outcome measure of this study is the achievement of voluntary movement of the upper extremity.



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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997125


Locations
United States, Ohio
The Ohio State University Wexner Medical Center - Center for Neuromodulation
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Marcia Bockbrader
Investigators
Principal Investigator: Marcia Bockbrader, MD, PhD Ohio State University

Publications of Results:
Responsible Party: Marcia Bockbrader, MD, PhD, Ohio State University
ClinicalTrials.gov Identifier: NCT01997125     History of Changes
Other Study ID Numbers: 2013H0164
2013H0164
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms