Jaimie M Henderson
Sponsored by
Jaimie M Henderson

Has your work performance been affected by a traumatic brain injury?

If so, you may qualify to participate in this clinical study.

Has your work performance been affected by a traumatic brain injury? If so, you may qualify to participate in this clinical study.

CENTURY-S | Traumatic brain injury trial in Stanford CA
NCT02881151 | Interventional

Has your work performance been affected by a traumatic brain injury?

If so, you may qualify to participate in this clinical study.

Has your work performance been affected by a traumatic brain injury? If so, you may qualify to participate in this clinical study.


What you may receive

Study related treatment at no cost

Study related procedures

Travel expenses covered

Medical related treatment

No insurance needed

Stanford Health Care

300 Pasteur Drive, Stanford, CA, USA 94305

Omar Rutledge (650) 206-0536

See more locations

Jaimie M Henderson
Sponsored by
Jaimie M Henderson
By signing up, you could possibly receive the newest treatment, help others and contribute to moving science forward.

Recruiting

Male & Female

22 - 60

years old

This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.

Why should I participate?

Traumatic Brain Injury or TBI is a leading cause of long-term disability worldwide. Severe TBI can be a result of several different incidents, such as a fall or motor vehicle accident.

The CENTURY-S trial is studying the use of a surgically implanted device called deep brain stimulation (DBS) for people who have suffered a severe traumatic brain injury. We believe that this intervention could improve concentration, mental focus, resistance to fatigue and/or attention span to significantly better occupational or academic functioning.

What's involved?

Interested individuals will undergo a thorough screening comprised of medical examinations, neuropsychological assessments and MRI scans. If eligible and interested in continuing in the study, participants will undergo surgery to place electrodes in the brain. The wires then route under the skin of the head and neck to connect to a device like a pacemaker, which is placed underneath the skin in the chest. After the procedure, participants will be followed by the research team for about one year. During that time, participants will be required to make sixteen visits to Stanford so the team can measure and record changes in thinking that include concentration, mental focus, resistance to fatigue and/or attention span.

Who can participate?

We are seeking individuals who have experienced a severe traumatic brain injury (defined as Glasgow Coma Scale score 3-9), and are at least two years post-injury. They can now make their own decisions and take care of their basic needs without assistance, but their difficulty in thinking caused by their TBI affects current occupational or academic performance.

You will need a study partner – someone who is close to you, such as a family member or close friend – who can attend certain study visits with you and help support your recovery process after surgery.

Where you'll go

Selected location

Stanford Health Care

Stanford Health Care Change

300 Pasteur Drive, Stanford, CA, USA 94305

Omar Rutledge (650) 206-0536

Get directions | Learn more

Stanford Health Care

300 Pasteur Drive, Stanford, CA, USA 94305
Omar Rutledge (650) 206-0536

Frequently Asked Questions
What is the goal of the research?

Our goal is to validate the use of the deep brain stimulator for the treatment of traumatic brain injuries. Particularly, we hope this system will help patients with memory functioning, attention and focus, and fatigue.

How long is the study?

The study is about a year for those who complete the entire study. You are free to withdraw from the research at any time during your participation.

Has this surgery been performed before?

Yes, this device is currently FDA-approved for the treatment of tremor associated with Parkinson’s disease as well as other indications. This is the first time we are using this system for patients with traumatic brain injuries.

Is the surgery risky?

Like all medical procedures, there is some risk associated with the implant surgery. The most common is the risk of infection, although the incidence of infection is still quite low. For a full description of risks, please contact the study coordinator.

What happens if there are complications?

Depending on the type of complication, we can decide whether or not to keep the system implanted. If we feel you are at a higher risk for injury if the system remains implanted, we will remove the system through an explant surgery.

What happens after the study is completed?

If the system works for you, you will be able to keep the system implanted after the study is completed at no cost to you. You will need to transfer your care to your local neurology department to maintain the system.

What is the long-term care of the deep brain stimulator?

The system is generally maintenance-free once the system is calibrated for your use. If you are exposed to high magnetic fields, your device may be turned off and will need to be recalibrated. The battery pack implanted under the skin of the chest will need to be replaced every 3-5 years, which will require a minor surgery.