Reanimation in Tetraplegia

August 5, 2021 updated by: Marcia Bockbrader

Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center - Center for Neuromodulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open Label
Neural bridge system implant and external stimulator
Implanted device
Other Names:
  • Blackrock Microsystems Neuroport
  • Neuromuscular Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Voluntary Movement
Time Frame: 9 months
The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcia Bockbrader, MD, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2013

Primary Completion (ACTUAL)

June 13, 2019

Study Completion (ACTUAL)

June 13, 2019

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (ESTIMATE)

November 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury (Quadraplegia)

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