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Reanimation in Tetraplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997125
Recruitment Status : Unknown
Verified August 2018 by Marcia Bockbrader, Ohio State University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 22, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE November 2013
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Voluntary Movement [ Time Frame: 9 months ]
The primary outcome measure of this study is the achievement of voluntary movement of the upper extremity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reanimation in Tetraplegia
Official Title  ICMJE Reanimation in Tetraplegia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Spinal Cord Injury (Quadraplegia)
Intervention  ICMJE Device: Neural Bridge System
Implanted device
Other Names:
  • Blackrock Microsystems Neuroport
  • Neuromuscular Stimulator
Study Arms  ICMJE Experimental: Open Label
Neural bridge system implant and external stimulator
Intervention: Device: Neural Bridge System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 27, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
5
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997125
Other Study ID Numbers  ICMJE 2013H0164
2013H0164
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcia Bockbrader, Ohio State University
Study Sponsor  ICMJE Marcia Bockbrader
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcia Bockbrader, MD, PhD Ohio State University
PRS Account Ohio State University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP