RESEARCH. BIOSPECIMENS

Baseline/Pre-enrollmentEnrollment/RandomizationTreatment

 1.   Patient Screening Worksheet "Pre-Treatment CRF Checklist"

 

2.   Actual Life Changes in Epilepsy

 

3.   Baseline Review of Medications

 

4.   Baseline Seizure Classification and Frequency Review

 

5.   Demographics and Medical History

 

6.   Focused Neuro Exam

 

7.   Formal Visual Fields Exam

 

8.   Headache and Mood

 

9.   HVLT-R Baseline

 

10. "Intracarotid" Wada Test

 

11. "Neuroimaging"

 

12. Neuropsychological Data Sheet (NP           Assessment India Version)

 

13. Pregnancy Test (female only)

 

14. Psychiatric History

 

15. QOLIE-89

 

16. "Standard Scalp EEG"

 

17. Video-EEG

18. MRI "UCSF Neuroradiology Baseline Screening MRI Review"

 

19. "Study Subject Participation Determination" [Patient is randomized or rejected]

20. Gamma Knife Radiosurgery Treatment arm (RS only)

 

21. "Temporal Lobectomy Treatment Arm" (ATL ony)

 

22. Pathology Evaluation Form (ATL Only) 

Post-op 01Post-op 03Post-op 06
 23. Telephone Follow-up 1 month

24. ATL Only : "Post Temporal Lobectomy Neuroradiology Data Form" [Note: coordinator should also send MRI along with the new 11. Neuroimaging form]

 

24.5 ATL Only: PostOp Physical Assessment

 

Actual Life Changes

 

Diary and Outpatient 

 

Focussed Neuro Exam 

 

Headache and Mood Post Treatment

 

Post Treatment Review of Medications

 

QOLIE-10

 

Seizure Diary

 

Post Treatment Seizure Classification and Frequency Review

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood Post Treatment

 

HVLT-R 

 

Post Treatment Review of Medications

 

QOLIE-10

 

Seizure Diary

 

Post Treatment Seizure Classification and Frequency Review

Post-op 09Post-op 12Post-op 15

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam

 

Headache and Mood Post Treatment

 

HVLT-R 

 

Post Treatment Review of Medications

 

QOLIE-10

 

Seizure Diary

 

Post Treatment Seizure Classification and Frequency Review

25. [Radiosurgery Arm Only]: Post Radiosurgery Neuroradiology Form. "Neuroradiology Form" should be sent with MRI

 

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood Post Treatment

 

HVLT-R 

 

Post Treatment Review of Medications

 

Seizure Diary

 

Post Treatment  Seizure Classification and Frequency Review

 

QOLIE-89

 

NP Assessment [India Version]

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood PostTreatment

 

HVLT-R 

 

PostTreatment Review of Medications

 

QOLIE-10

 

Seizure Diary

 

PostTreatment Seizure Classification and Frequency Review 

Post-op 18Post-op 21Post-op 24

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood PostTreatment

 

HVLT-R 

 

Post Treatment Review of Medications

 

QOLIE-10

 

Seizure Diary

 

Post Treatment Seizure Classification and Frequency Review

Telephone Follow Up 

25. [Radiosurgery Arm Only]: Post Radiosurgery Neuroradiology Form "Neuroradiology Form" should be sent with MRI

 

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood PostTreatment

 

HVLT-R 

 

Post Treatment Review of Medications

 

Seizure Diary

 

Post Treatment Seizure Classificaiton and Frequency Review

 

QOLIE-89

 

NP Assessment [India Version]

 

Formal VIsual Fields Exam

Post-op 27Post-op 30Post-op 33

 

Telephone Follow up

 

Telephone Follow upTelephone Follow up
Post-op 36Any Post-op (As needed) 

25. [Radiosurgery Arm Ony]: Post Radiosurgery Neuroradiology Form. Neuroradiology Form should be sent with MRI

 

Actual Life Changes

 

Diary and Outpatient Billing

 

Focussed Neuro Exam 

 

Headache and Mood Post Treatment

 

HVLT-R

 

Post Treatment Review of Medications

 

Seizure Diary

 

Post Treatment Seizure Classification and Frequency Review

 

QOLIE-89

 

NP Assessment [India Version]

 

End of Study Form

 

 

Adverse Event