Parkinson Disease
Conditions
Keywords
STN, DBS, steering, segmented electrode leads
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).
Interventions
DEVICEOmnidirectional Deep Brain Stimulation of STN
Deep Brain Stimulation
DEVICEDirectional Deep Brain Stimulation of STN
Deep Brain Stimulation
Sponsors
University Hospital Tuebingen
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Rigidity | 6 months post-operatively | Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical motor and non-motor symptoms (1) | 6 months post-operatively | MDS-UPDRS I |
| Clinical motor and non-motor symptoms (2) | 6 months post-operatively | MDS-UPDRS II |
| 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 symptoms |
| Clinical 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) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAlireza Gharabaghi, MD
Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany
PRINCIPAL_INVESTIGATORDaniel Weiss, MD
Department for Neurodegenerative Diseases, Centre for Neurology, Tuebingen, Germany, and Hertie-Institute for Clinical Brain Research
Outcome results
None listed