Medical Student Research Fellowship for Summer 2010
Mentor: Mark Johnson
Mail Code: 8897
Phone number: 214-648-7811
Project title: Combined Donepezil and Dextroamphetamine in the Treatment of Aphasia
Human subjects IRB approved project number (where applicable): #032006-089
Animal subjects IRB approved project number (where applicable): N/A
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)
Brief Description of Project:
The purpose of this prospective randomized double blinded study is to compare three groups of therapy: combined Dextroamphetamine and Donepezil, Donepezil alone, and placebo as well as determine the efficacy of using pharmacologic treatment paired with learning dependent experience to accelerate recovery from aphasia following a stroke.
This study is being done to determine if using medicine therapy along with
speech language therapy increases the rate of recovery from speech difficulties
after a stroke (aphasia) and to determine if that recovery lasts over time.
The study drugs to be used are Dextroamphetamine sulfate and Donepezil
Subjects will be assigned randomly to receive either one study drug plus speech therapy, two study drugs plus speech therapy, or placebo (inactive substance) and speech therapy.
There will be 4 speech-language therapy sessions per week for 6 weeks. Each speech-language therapy session will last 1 ½ hours. Medications will be given as part of the trial.
Procedures and Evaluations during the Research
The following tests and/or evaluations will be done:
" National Institutes of Health Stroke Scale (NIHSS) - a brief neurological exam used to assess your brain functioning. This test takes about 15 minutes.
" A speech and language evaluation that takes 3 to 4 hours will include:
o Porch Index of Communicative Ability (PICA) - a general language test that tests your ability to speak, listen, read, and write words, sentences, and paragraphs.
o The Western Aphasia Battery (WAB) - another general language test that tests your ability to speak, listen, read, and write words, sentences, and paragraphs.
o Communicative Effectiveness Index (CETI) - a test given to one of your family member members so that family member can rate your speech and language in a variety of situations in your home environment with family and friends.
" Magnetic Resonance Imaging (MRI) scan of the brain around the time of Visit 1 and before the start the study drugs. The MRI will take about 40 minutes.
Visits 2 through 25 - These visits will occur every Monday, Tuesday, Wednesday,
and Thursday for 6 weeks.
" blood pressure and heart rate will be checked at the beginning of each visit and at the end of each visit
" Subject will receive a study drug.
" 30 minutes after you receive the study drug, you will have a 90 minute speech and language therapy session that will focus on your speech and language problems that were found during the speech and language evaluation during Visit 1.
Visit 26 - This visit will occur about 1 week after the subject has completed
the 6 weeks of study drugs and speech and language therapy.
" NIHSS - takes about 15 minutes
" MRI of your brain - will take about 40 minutes
Visit 27 - Similar Studies as in Visit #1
Mrs. Seidel has neurolinguistics expertise and she will assist in the above process as per therapist assignment. She will participate in the language treatments as performed by the speech therapist.
Also we would like for her to participate in retrospective analysis of available data. This retrospective analysis is yet to be defined.
This is an ongoing study.
We have 6 patient s enrolled and we are hoping to reach 24 patients
Previous Research Activities or Publications with Medical Students: