Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (\>130Hz) stimulation, 2) cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
RECRUITINGChange in the part II of the Unified Parkinson's disease rating scale
The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in the New Freezing of Gait Questionnaire
The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in Falls Efficacy Scale
The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in The Parkinson's Disease Questionnaire (PDQ-39)
This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale)
The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.
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Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Number of falls
Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.
Time frame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks