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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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].
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN_O | Active Comparator | Omnidirectional Deep Brain Stimulation of STN |
|
| STN_D | Experimental | Directional Deep Brain Stimulation of STN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnidirectional Deep Brain Stimulation of STN | Device | Deep Brain Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Rigidity | Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii | 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical motor and non-motor symptoms (1) | MDS-UPDRS I | 6 months post-operatively |
| Clinical motor and non-motor symptoms (2) | MDS-UPDRS II |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalography | Electroencephalography (EEG) | up to 6 months post-operatively |
| Electromyography | Electromyography (EMG) | up to 6 months post-operatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alireza Gharabaghi, MD | Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany | Principal Investigator |
| Daniel Weiss, MD | Department for Neurodegenerative Diseases, Centre for Neurology, Tuebingen, Germany, and Hertie-Institute for Clinical Brain Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen, Dep. of Neurosurgery (Functional Neurosurgery) and Neurology (Neurodegenerative Diseases) | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18855925 | Background | Levin J, Krafczyk S, Valkovic P, Eggert T, Claassen J, Botzel K. Objective measurement of muscle rigidity in Parkinsonian patients treated with subthalamic stimulation. Mov Disord. 2009 Jan 15;24(1):57-63. doi: 10.1002/mds.22291. | |
| 39461964 | Derived | Gharabaghi A, Cebi I, Leavitt D, Scherer M, Bookjans P, Brunnett B, Milosevic L, Weiss D. Randomized crossover trial on motor and non-motor outcome of directional deep brain stimulation in Parkinson's disease. NPJ Parkinsons Dis. 2024 Oct 26;10(1):204. doi: 10.1038/s41531-024-00812-0. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Directional Deep Brain Stimulation of STN |
| Device |
Deep Brain Stimulation |
|
| 6 months post-operatively |
| Clinical motor and non-motor symptoms (3) | MDS-UPDRS III | 6 months post-operatively |
| Clinical motor and non-motor symptoms (4) | MDS-UPDRS IV | 6 months post-operatively |
| Clinical motor and non-motor symptoms (5) | Bradykinesia evaluation | 6 months post-operatively |
| Clinical motor and non-motor symptoms (6) | Tremor evaluation | 6 months post-operatively |
| Clinical motor and non-motor symptoms (7) | Deep brain stimulation impairment scale (DBS-IS):
| 6 months post-operatively |
| Clinical motor and non-motor symptoms (8) | Clinical global impression self | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (1) | Modulation range | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (2) | Spatial with a visual Odd-Ball test | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (3) | Verbal Working Memory with an auditory Odd-Ball test | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (4) | Power of Attention (Cognitive Drug Research Battery) | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (5) | Digit Vigilance Accuracy (Cognitive Drug Research Battery) | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (6) | Executive functions with One Touch Tower of London (Cambridge Neuropsychological Test Automated Battery, CANTAB) | 6 months post-operatively |
| Neurocognitive and non-motor symptoms (7) | Montreal Cognitive Assessment (MoCA) | 6 months post-operatively |
| Neuropsychiatric symptoms (1) | Beck Depression Inventory (BDI) | 6 months post-operatively |
| Neuropsychiatric symptoms (2) | Apathy Scale/Lille Apathy rating scale/Neuropsychiatric inventory | 6 months post-operatively |
| Freezing of gait (1) | Capsit-PD | 6 months post-operatively |
| Freezing of gait (2) | Freezing of Gait Assessment Course | 6 months post-operatively |
| Quality of Life | Parkinson's Disease Questionaire (PDQ-39) | 6 months post-operatively |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |