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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00792-49 | Registry Identifier | ID RCB |
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Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedunculopontine stimulation | Active Comparator | Deep brain stimulation of the pedunculopontine area |
|
| Pontomesencephalic stimulation | Active Comparator | Deep brain stimulation of the pontomesencephalic area |
|
| Sham stimulation | Sham Comparator | No deep brain stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Stimulating deep brain electrodes and pulse generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the anticipatory postural adjustments between each deep brain stimulation condition | 3, 5, 7 months after surgery |
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Laure Welter, MD, PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34744048 | Result | Bourilhon J, Olivier C, You H, Collomb-Clerc A, Grabli D, Belaid H, Mullie Y, Francois C, Czernecki V, Lau B, Perez-Garcia F, Bardinet E, Fernandez-Vidal S, Karachi C, Welter ML. Pedunculopontine and Cuneiform Nuclei Deep Brain Stimulation for Severe Gait and Balance Disorders in Parkinson's Disease: Interim Results from a Randomized Double-Blind Clinical Trial. J Parkinsons Dis. 2022;12(2):639-653. doi: 10.3233/JPD-212793. | |
| 35121249 |
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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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| Sham stimulation | Device |
|
| Result |
| Bourilhon J, Mullie Y, Olivier C, Cherif S, Belaid H, Grabli D, Czernecki V, Karachi C, Welter ML. Stimulation of the pedunculopontine and cuneiform nuclei for freezing of gait and falls in Parkinson disease: Cross-over single-blinded study and long-term follow-up. Parkinsonism Relat Disord. 2022 Mar;96:13-17. doi: 10.1016/j.parkreldis.2022.01.010. Epub 2022 Jan 22. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |