Trials / Unknown
UnknownNCT04408573
Cycling Deep Brain Stimulation on Parkinson's Disease Gait
Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cycling deep brain stimulation | Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2021-05-29
- Completion
- 2021-12-29
- First posted
- 2020-05-29
- Last updated
- 2020-06-23
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04408573. Inclusion in this directory is not an endorsement.