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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00387-34 | Other Identifier | ID-RCB |
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Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.
The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Electrical stimulation of the nucleus basalis of Meynert | Sham Comparator | Deep brain stimulation |
|
| Electrical stimulation of the nucleus basalis of Meynert | Experimental | Deep brain stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation of the nucleus basalis of Meynert | Procedure | Differents parameters will be assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| free recalls of the FCSRT | The primary endpoint of the study is the difference in the sum of the three free recalls of the FCSRT between the assessments (M7) and (M10), i.e. the comparison of the performances with and without NBM electrical stimulation. | between the assessments (Month 7) and (Month 10) |
| Measure | Description | Time Frame |
|---|---|---|
| performances on different tests | Comparison will be made between the performances on different tests recorded at M7 and M10, to evaluate the effect of bilateral electrical stimulation of the NBM on cognitivo-behavioral disorders. | different tests recorded at Month 7 and Month 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier GODEFROY, Md, PhD | University Hospital of Amiens | Principal Investigator |
| Luc DEFEBVRE, MD, PhD | University Hospital of Lille | Principal Investigator |
| HOUETO Jean-Luc, MD, PhD | Poitiers University Hospital | Principal Investigator |
| Pierre Krystkowiak, MD, PhD | University Hospital of Amiens | Principal Investigator |
| Vincent Delasayette, MD | University Hospital of Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maltête David | Rouen | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33199437 | Derived | Maltete D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16. |
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| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |