Clinical trial NCT04408573: Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Official title: Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 weeks of regular continuous high frequency (\>130Hz) stimulation, 2 weeks of cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
* Hoehn \& Yahr stage between 2-4 during off-medication
* Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
* Willingness to comply with all study procedures

Exclusion Criteria:

* Active moderate/severe psychiatric condition
* Active infection or other uncontrolled moderate/grave comorbidities
* Treatment with experimental drug
* Pregnancy or breast-feeding

Primary outcomes:
measure: Change in the part II of the Unified Parkinson's disease rating scale
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
measure: Change in the New Freezing of Gait Questionnaire
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary outcomes:
measure: Change in Falls Efficacy Scale
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
measure: Change in The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
measure: Change in Activities-Specific Balance Confidence Scale (ABC scale)
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
measure: Number of falls
timeFrame: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Rubens G Cury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: