Subthalamic Steering for Therapy Optimization in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Directional Deep Brain Stimulation of STNDevice: Omnidirectional Deep Brain Stimulation of STN
- Registration Number
- NCT03548506
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \[STN_O\] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact \[STN_D\].
- Detailed Description
Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation \[STN_D\] compared with standard omnidirectional STN stimulation \[STN_O\]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P \< 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Written informed consent
- Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
- Cognitive impairment (Mini Mental State Exam < 20)
- Suicidality, Psychosis
- Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description STN_D Directional Deep Brain Stimulation of STN Directional Deep Brain Stimulation of STN STN_O Omnidirectional Deep Brain Stimulation of STN Omnidirectional Deep Brain Stimulation of STN
- Primary Outcome Measures
Name Time Method Muscle Rigidity 6 months post-operatively Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii
- Secondary Outcome Measures
Name Time Method Clinical motor and non-motor symptoms (2) 6 months post-operatively MDS-UPDRS II
Clinical motor and non-motor symptoms (1) 6 months post-operatively MDS-UPDRS I
Clinical motor and non-motor symptoms (3) 6 months post-operatively MDS-UPDRS III
Clinical motor and non-motor symptoms (4) 6 months post-operatively MDS-UPDRS IV
Clinical motor and non-motor symptoms (5) 6 months post-operatively Bradykinesia evaluation
Clinical motor and non-motor symptoms (6) 6 months post-operatively Tremor evaluation
Clinical motor and non-motor symptoms (7) 6 months post-operatively Deep brain stimulation impairment scale (DBS-IS):
* the scale consists of 22 questions and 6 subscales;
* subscales: 1. postural instability and gait difficulties (range 0-20), 2. cognitive impaiment (range 0-20), 3. speaking problems (range 0-12), 4. apathy (range 0-12), 5. impulsivity (range 0-12), and 6. difficulties related to DBS device (range 0-12);
* Ʃ 1-6 DBS-IS total range: 0-88;
* Ʃ 1-5 DBS-IS total range: 0-76;
* higher values represent worsening of symptomsClinical motor and non-motor symptoms (8) 6 months post-operatively Clinical global impression self
Neurocognitive and non-motor symptoms (1) 6 months post-operatively Modulation range
Neurocognitive and non-motor symptoms (2) 6 months post-operatively Spatial with a visual Odd-Ball test
Neurocognitive and non-motor symptoms (3) 6 months post-operatively Verbal Working Memory with an auditory Odd-Ball test
Neurocognitive and non-motor symptoms (4) 6 months post-operatively Power of Attention (Cognitive Drug Research Battery)
Neurocognitive and non-motor symptoms (5) 6 months post-operatively Digit Vigilance Accuracy (Cognitive Drug Research Battery)
Neurocognitive and non-motor symptoms (6) 6 months post-operatively Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB)
Neurocognitive and non-motor symptoms (7) 6 months post-operatively Montreal Cognitive Assessment (MoCA)
Neuropsychiatric symptoms (1) 6 months post-operatively Beck Depression Inventory (BDI)
Neuropsychiatric symptoms (2) 6 months post-operatively Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory
Freezing of gait (1) 6 months post-operatively Capsit-PD
Freezing of gait (2) 6 months post-operatively Freezing of Gait Assessment Course
Quality of life 6 months post-operatively Parkinson's Disease Questionaire (PDQ-39)
Trial Locations
- Locations (1)
University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases)
🇩🇪Tuebingen, Baden-Wuerttemberg, Germany