Assessment | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 |
---|---|---|---|---|---|---|---|---|---|
Screen | Baseline assessment | Surgical screening | Surgery | 2-week F/U | 6-week F/U | 12-week F/U | 24-week F/U | 25-week F/U | |
Screening ICF | X | ||||||||
Pre-op work up* (CBC, CMP, β-hCG, INR/PTT/PT, U/A, EKG, CXR) | X | X | |||||||
Neuropsychiatric evaluation (including MDRS and BDI) | X | X | X | X | X | X | X | ||
Columbia Suicide Severity Rating Scale | X | X | X | X | X | X | X | ||
Gait assessment | X | X | X | X | X | X | |||
MDS-UPDRS | X | X | X | X | X | X | |||
FOG Questionnaire | X | X | X | X | X | ||||
Timed Up and Go test | X | X | X | X | X | ||||
Velocity test | X | X | X | X | X | ||||
Variability test | X | X | X | X | X | ||||
PDQ-39 | X | X | X | X | X | X | |||
PDQL | X | X | X | X | X | X | |||
Brief pain history and NPSI | X | X | X | X | X | X | |||
Surgical ICF | X | ||||||||
MRI | X | ||||||||
Device implantation | X | ||||||||
CT scan | X | ||||||||
EMG analysis | X | X | X | ||||||
Programming | X | X | X | X | X | ||||
Gait kinematics | X | X |