Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Vercise DBS System
- Registration Number
- NCT04218526
- Lead Sponsor
- Jonathan Jagid
- Brief Summary
The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vercise DBS Group Vercise DBS System All participants will have the Vercise DBS system implanted.
- Primary Outcome Measures
Name Time Method Percent change in UPDRS Part III on/off stimulation Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op Percent change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III on/off stimulation across study visits relative to pre-operative assessment
Percent Change in Gait Velocity Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op Percent change in gait velocity with and without bilateral cuneiform nucleus deep brain stimulation. Over a distance of 3 meters, gait velocity will be measured using the timed Up and Go test instrumented with Mobility Lab accelerometers.
- Secondary Outcome Measures
Name Time Method Percent Change in Muscle Amplitude Baseline, 24 weeks Percent change in muscle amplitude during gait testing using electromyography (EMG)
Percent Change in number of Falls Baseline, 24 weeks Percent change in number of falls during gait testing sessions and on item 13 of UPDRS III (falls unrelated to freezing)
Percent Change in PDQ 39 Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op Parkinson's Disease Questionnaire (PDQ-39) is 39-item questionnaire with a total score ranging from 0-156 with the higher score indicating poorer quality of life.
Percent Change in PDQ-L Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op Parkinson's Disease Quality of Life Questionnaire is a 37-item questionnaire with a total score ranging from 0-185 with the higher score indicating poorer quality of life.
Percent Change in FOG Questionnaire Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op Freezing of Gait (FOG) Questionnaire is a 6-item questionnaire with each item scored from 0-4. The total score ranges from 0-24 with the higher score indicating more severe freezing of gait .
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States