Questions You Might Have About the Study of the Effectiveness of Amatadine in Promoting Recovery of Function after Brain Injury

What is the purpose of this research project?

After traumatic brain injury, some people remain unconscious or minimally conscious for weeks or months. A number of treatments have been tried to help these patients. Doctors often try to help patients improve faster by giving them medications because these medications may improve the balance of chemicals (neurotransmitters) in the brain. Because of limited previous research, doctors do not have a clear basis for making decisions about prescribing medications to unconscious or minimally conscious patients.

Our center and 7 other centers across the United States and 1 in Germany are conducting a research project to help obtain information doctors need to help with decisions to prescribe medications.

This study will help determine:

· whether a particular medication (amantadine) improves recovery after brain injury

· if improvement is maintained after the medication is stopped

· when medication should be given

· whether patients with certain types of injuries are more likely to benefit from medication

Why is this research needed?

· medications used to improve responsiveness in patients with disorders of consciousness have not been shown to be effective

· these medications may help patients, but it is possible that they cause side effects

· previous studies have not given doctors clear information about whether or not to prescribe medications for patients with disorders of consciousness

Why is amantadine the medication chosen for the study?

· it affects a brain chemical that may be important to recovery

· it works rapidly

· some earlier studies suggest that it might help

· it has been used for a long time and is known to have few side effects

Who is eligible to participate?

· patients who have brain injury with a disorder of consciousness

· patients who are not consistently able to follow commands

· patients who are between 4 and 16 weeks post injury

· patients who meet specific medical requirements

If you give permission (consent) for your family member to participate he/she would:

· receive amantadine or a placebo (a liquid without any medication) for 4 weeks

· be monitored very carefully to look for signs of progress, any problems, or side effects

· be assessed while taking the medication and 2 weeks after the medication is stopped

· be taken off the medication if there is a sign of a problem that may be related to the study

· have some limits on other medications he/she can take for 6 weeks

· receive a CT scan of the head at no charge if he/she has not had a head CT in 2 weeks or is not scheduled to have a head CT within 2 weeks

How would my family member be assigned to a group?

He/she would be randomly assigned to the treatment group (receiving amantadine) or the placebo group (receiving a liquid without medication). This is like flipping a coin to determine the group assignment.

How would my family member’s function be assessed?

Once in the study, your family member would be regularly assessed with simple tests that measure how well your family member responds to sights, sounds, and verbal directions. These tests are the:

· Disability Rating Scale

· Coma Recovery Scale-Revised

What effect would my family member’s participation have on their rehabilitation program?

The therapy program would remain the same. The medical treatment would also remain the same, except that there would be limitations on the use of some medications that could effect cognition and interfere with the ability to determine the effects of amantadine

Under what circumstance would my family member’s participation in the study be stopped?

· if you change your mind and decide not to let him/her participate

· if his/her physician thinks that continuing is against your family member’s best interests

· if your family member has new seizures or an increase in seizure frequency or severity

Why would you want to you give permission (consent) for your family member to participate?

· this research may benefit persons who have brain injuries in the future

· any risk to your family member is low

· any information about your family member obtained as part of this study will be kept confidential

· there is no cost for participating in this study