Table 1.
Detailed study schedule
| 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 |
BDI Beck Depression Inventory, β-hCG Beta human chorionic gonadotropin, CBC complete blood count, CMP comprehensive metabolic panel, CT computed tomography, CXR chest x-ray, EKG electrocardiogram, EMG electromyogram, FOG freezing of gait, F/U follow-up, INR international normalized ratio, NPSI Neuropathic Pain Symptom Inventory, MDRS Mattis Dementia Rating Scale, MDS-UPDRS Movement Disorder Society Unified Parkinson’s Disease Rating Scale, MRI magnetic resonance imaging, PDQ-39 Parkinson’s Disease Questionnaire-39, PDQL Parkinson’s Disease Quality of Life questionnaire, PT prothrombin time, PTT partial thromboplastin time, U/A urinalysis
*Pre-op labs are viable for 30 days before surgery. After 30 days, they must be repeated before surgical procedure