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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata [STN+SNr].
A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts [STN+SNr] in refractory hypokinetic gait disturbances compared with [STNmono] (active comparator). The results will clarify, whether the combined [STN+SNr] stimulation improves otherwise refractory gait disturbances in PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [STNmono] | Active Comparator | Conventional stimulation on subthalamic contacts |
|
| [STN+SNr] | Experimental | Combined subthalamic and nigral stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation (ACTIVA PC, Medtronic) | Device | High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude) |
| Measure | Description | Time Frame |
|---|---|---|
| 'Axial score' | The composite 'axial score' is built by 8 items from the UPDRS II and III, all 5-point rated (0 to 4) representing increasing levels of pathology. The 'axial score' will be scored by the sum of the ratings across the 8 items (Range 0 to 32). As change in UPDRS scores is a common primary efficacy outcome measure in Parkinson's disease and only items of the original UPDRS are required for the definition of the primary endpoint, the statistical evaluation methods should be based on the psychometric validation of the UPDRS and no own validation studies are necessary. Safety: falls | Three weeks after active treatment (STN vs. STN+SNr), respectively |
| Measure | Description | Time Frame |
|---|---|---|
| CAPSIT-PD | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively | |
| Freezing of gait assessment course | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weiss, MD | Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen | Principal Investigator |
| Rejko Krüger, MD | Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21287187 | Background | Weiss D, Breit S, Wachter T, Plewnia C, Gharabaghi A, Kruger R. Combined stimulation of the substantia nigra pars reticulata and the subthalamic nucleus is effective in hypokinetic gait disturbance in Parkinson's disease. J Neurol. 2011 Jun;258(6):1183-5. doi: 10.1007/s00415-011-5906-3. Epub 2011 Feb 2. No abstract available. | |
| 21989388 |
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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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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Freezing of gait questionnaire | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Berg Balance Scale | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Non-motor symptoms scale | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Non-motor symptoms quest | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Beck's depression scale index | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Minnesota Impulsive Disorders Interview | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Barratt Impulsiveness Scale | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| UPDRS I-IV | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| PDQ-39 | At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively |
| Weiss D, Wachter T, Meisner C, Fritz M, Gharabaghi A, Plewnia C, Breit S, Kruger R. Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2011 Oct 11;12:222. doi: 10.1186/1745-6215-12-222. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |