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Table 1 Detailed study schedule

From: Deep brain stimulation of the Cuneiform nucleus for levodopa-resistant freezing of gait in Parkinson’s disease: study protocol for a prospective, pilot trial

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

  1. 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
  2. *Pre-op labs are viable for 30 days before surgery. After 30 days, they must be repeated before surgical procedure