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Clinical Trials

Clinical studies (approved by the local Investigational Review Board) are undertaken with full informed consent of the patient. Safety and efficacy are prioritized, with full disclosure to patients. These trials usually involve materials or methods for treatment of disorders where it remains unknown whether a superior method exists. Examples considered range from drug trials for terminal cancer to new materials substituting existing implantable devices.

We are presently involved in the following clinical trials:   

1)   Evaluating the safety and effectiveness of DURAGEN PLUS™

DURAGEN PLUS™ is a device used for the purpose of preventing or minimizing adhesions or scars that may develop following single level surgical removal of a herniated lumbar disc (also known as a “bulging disk” or “ruptured disk” or “slipped disk”). *Stopped enrolling per company's study was terminated by Integra.

 

2)   Evaluating the safety and effectiveness of INFUSE® Bone Graft for patients undergoing cervical disk removal and fusion in the cervical spine (neck).

This investigational device is designed to help fusion take place between two cervical vertebrae following surgical removal of a herniated cervical disc.  *Stopped enrolling as study met enrollment goal.

 

3)   Evaluating the safety and effectiveness of Deep Brain Stimulation for patients with Dystonia (under a “humanitarian device exemption”).

Dystonia is a neurological movement disorder, with stiffness of certain muscles.  If medications fail, this can be a good option for selected cases.

 

4)   Vagus nerve stimulation for depression. (Criteria are evaluated in conjunction with Brentwood Hospital). 
For qualifying patients with severe, recurrent, chronic depression which has not been treated by multiple medications, this device may offer improvement in selected cases.  *Study terminated by Cyberonics. 

 

By participating in a clinical trial, participants contribute to the development of treatments that may help others in the future, and gain access to treatments before they are widely available. Choosing to participate is completely voluntary and should be based on personal needs and interests. Safety and efficacy are prioritized, with full disclosure to patients. Before participating in a clinical trial, patients should understand the potential risks and benefits. 

Clinical trials, lasting from a few weeks to many years, determine how safe and effective new  treatments may be. Trials and studies currently underway at the Interactive Neuroscience Center range from one year to several years.  All clinical trials have guidelines about who can participate. Using pre-established criteria to help produce reliable results, patients are screened to see if they qualify.  This process helps to identify appropriate participants and keep them safe. Patients interested in participating in our current clinical trials should contact Tim Gilbert, Clinical Research Director, at 318-797-5543.
 

 

Last Modified: April 8, 2010

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