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Deep brain stimulation of the NST is effective for cardinal motor signs in patients with idiopathic Parkinson's disease (IPD), its effects on gait disturbances, especially freezing of gait-FOG, and falls are variable from one patient to another, in part depending on the location of the NST-stimulating contact. The ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for NSC SCP patients with Parkinson's disease. In this pilot research program, the main objective is to determine the impact of directional DBS on gait and balance issues for PD patients implanted in the STN, using previously described anatomical and functional data for gait disturbances to guide directional programming. Ten patients with Patients with severe form of Parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two French sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ring STN-DBS | Active Comparator | The order of the five STN-DBS stimulation conditions will be randomized and assessments will be performed blinded from the stimulation condition. The effects of STN DBS on gait recordings will be assessed in 5 different conditions: with single ring DBS (1), and with current shaping for DBS of the gait 'hot spot' (2), of the dorsal STN (3) of the ventral STN (4) and of the DBS of narrow fiber tracts (5). The first condition will always be the single ring DBS. |
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| Directional STN-DBS | Experimental | The order of the five STN-DBS stimulation conditions will be randomized and assessments will be performed blinded from the stimulation condition. The effects of STN DBS on gait recordings will be assessed in 5 different conditions: with single ring DBS (1), and with current shaping for DBS of the gait 'hot spot' (2), of the dorsal STN (3) of the ventral STN (4) and of the DBS of narrow fiber tracts (5). The first condition will always be the single ring DBS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Directional and single ring STN-DBS on gait | Procedure | Surgery for STN-DBS and STN-LFP recordings during gait initiation (M1): 15 days
Follow-up of the patient with outpatient visits as usually performed in PD patients operated for STN-DBS with progressive adaptation of parameters settings using single-ring stimulation. Directional and single ring STN-DBS on gait (M7) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference | The primary endpoint will be the changes in Euclidian distance in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference (Go, No Go paradigm), reproducing at least partly situations where FOG occurred, between stimulation conditions (Varriale, Collomb-Clerc, et al., 2018). | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de ROUEN | Rouen | France | 76000 | France |
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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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The order of the five STN-DBS stimulation conditions will be randomized and assessments will be performed blinded from the stimulation condition. The effects of STN DBS on gait recordings will be assessed in 5 different conditions: with single ring DBS (1), and with current shaping for DBS of the gait 'hot spot' (2), of the dorsal STN (3) of the ventral STN (4) and of the DBS of narrow fiber tracts (5). The first condition will always be the single ring DBS.
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |