David Maltête1, David Wallon2, Julie Bourilhon2, Romain Lefaucheur2, Teodor Danaila2, Stéphane Thobois2, Luc Defebvre2, Kathy Dujardin2, Jean-Luc Houeto2, Olivier Godefroy2, Pierre Krystkowiak2, Olivier Martinaud2, André Gillibert2, Mathieu Chastan2, Pierre Vera2, Didier Hannequin2, Marie-Laure Welter2, Stéphane Derrey2. 1. From the Departments of Neurology (D.M., D.W., R.L., D.H.), Neurophysiology (J.B., M.-L.W.), and Neurosurgery (S.D.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Department of Neurology C (T.D., S.T.), Hopital Neurologique Pierre Wertheimer, University of Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux; Department of Neurology (L.D., K.D.), Lille University Hospital, INSERM 1171; Department of Neurology (J.-L.H.), CIC-INSERM 1402, CHU de Poitiers; Université de Poitiers (J.-L.H.); Department of Neurology (O.G., P.K.), Amiens University Hospital; Department of Neurology (O.M.), Caen University Hospital; Department of Biostatistics (A.G.), Rouen University Hospital; Department of Nuclear Medicine (M.C., P.V.), Henri Becquerel Cancer Center and Rouen University Hospital; and QuantIF-LITIS [EA (Equipe d'Accueil) 4108-FR CNRS 3638] (M.C., P.V.), Faculty of Medicine, University of Rouen, France. david.maltete@chu-rouen.fr. 2. From the Departments of Neurology (D.M., D.W., R.L., D.H.), Neurophysiology (J.B., M.-L.W.), and Neurosurgery (S.D.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Department of Neurology C (T.D., S.T.), Hopital Neurologique Pierre Wertheimer, University of Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux; Department of Neurology (L.D., K.D.), Lille University Hospital, INSERM 1171; Department of Neurology (J.-L.H.), CIC-INSERM 1402, CHU de Poitiers; Université de Poitiers (J.-L.H.); Department of Neurology (O.G., P.K.), Amiens University Hospital; Department of Neurology (O.M.), Caen University Hospital; Department of Biostatistics (A.G.), Rouen University Hospital; Department of Nuclear Medicine (M.C., P.V.), Henri Becquerel Cancer Center and Rouen University Hospital; and QuantIF-LITIS [EA (Equipe d'Accueil) 4108-FR CNRS 3638] (M.C., P.V.), Faculty of Medicine, University of Rouen, France.
Abstract
OBJECTIVES: Nucleus basalis of Meynert deep brain stimulation (NBM-DBS) has been proposed for patients with dementia. Here, we aim to assess the safety and effects of NBM-DBS in patients with Lewy body dementia (LBD), in a randomized, double-blind, crossover clinical trial. METHODS: Six patients with mild to moderate LBD (mean [SD] age, 62.2 [7.8] years) were included, operated on for bilateral NBM-DBS, and assigned to receive either active or sham NBM-DBS followed by the opposite condition for 3 months. The primary outcome was the difference in the total free recalls of the Free and Cued Selective Reminding Test (FCSRT) between active and sham NBM-DBS. Secondary outcomes were assessments of the safety and effects of NBM-DBS on cognition, motor disability, sleep, and PET imaging. RESULTS: There was no significant difference in the FCSRT score with active vs sham NBM-DBS. The surgical procedures were well tolerated in all patients, but we observed significant decreases in Stroop and Benton scores after electrode implantation. We observed no significant difference in other scales between active and sham NBM-DBS. With active NBM-DBS relative to baseline, phonemic fluency and motor disability significantly decreased. Lastly, the superior lingual gyrus metabolic activity significantly increased with active NBM-DBS. CONCLUSIONS: NBM-DBS does not appear to be totally safe for patients with LBD with no evidence of cognitive benefit. CLINICALTRIALSGOV IDENTIFIER: NCT01340001. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, for patients with LBD operated on for bilateral NBM-DBS, active NBM-DBS stimulation compared to sham stimulation did not significantly change selective recall scores.
OBJECTIVES: Nucleus basalis of Meynert deep brain stimulation (NBM-DBS) has been proposed for patients with dementia. Here, we aim to assess the safety and effects of NBM-DBS in patients with Lewy body dementia (LBD), in a randomized, double-blind, crossover clinical trial. METHODS: Six patients with mild to moderate LBD (mean [SD] age, 62.2 [7.8] years) were included, operated on for bilateral NBM-DBS, and assigned to receive either active or sham NBM-DBS followed by the opposite condition for 3 months. The primary outcome was the difference in the total free recalls of the Free and Cued Selective Reminding Test (FCSRT) between active and sham NBM-DBS. Secondary outcomes were assessments of the safety and effects of NBM-DBS on cognition, motor disability, sleep, and PET imaging. RESULTS: There was no significant difference in the FCSRT score with active vs sham NBM-DBS. The surgical procedures were well tolerated in all patients, but we observed significant decreases in Stroop and Benton scores after electrode implantation. We observed no significant difference in other scales between active and sham NBM-DBS. With active NBM-DBS relative to baseline, phonemic fluency and motor disability significantly decreased. Lastly, the superior lingual gyrus metabolic activity significantly increased with active NBM-DBS. CONCLUSIONS: NBM-DBS does not appear to be totally safe for patients with LBD with no evidence of cognitive benefit. CLINICALTRIALSGOV IDENTIFIER: NCT01340001. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, for patients with LBD operated on for bilateral NBM-DBS, active NBM-DBS stimulation compared to sham stimulation did not significantly change selective recall scores.
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