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An updated overview of recent and ongoing deep brain stimulation (DBS) trials in patients with dementia: a systematic review

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Abstract

Background

Dementia affects more than 55 million people worldwide. Several technologies have been developed to slow cognitive decline: deep brain stimulation (DBS) of network targets in Alzheimer’s disease (AD) and dementia with Lewy bodies (DLB) have been recently investigated.

Objective

This study aimed to review the characteristics of the populations, protocols, and outcomes of patients with dementia enrolled in clinical trials investigating the feasibility and efficacy of DBS.

Materials and methods

A systematic search of all registered RCTs was performed on Clinicaltrials.gov and EudraCT, while a systematic literature review was conducted on PubMed, Scopus, Cochrane, and APA PsycInfo to identify published trials.

Results

The literature search yielded 2122 records, and the clinical trial search 15 records. Overall, 17 studies were included. Two of 17 studies were open-label studies reporting no NCT/EUCT code and were analysed separately. Of 12 studies investigating the role of DBS in AD, we included 5 published RCTs, 2 unregistered open-label (OL) studies, 3 recruiting studies, and 2 unpublished trials with no evidence of completion. The overall risk of bias was assessed as moderate-high. Our review showed significant heterogeneity in the recruited populations regarding age, disease severity, informed consent availability, inclusion, and exclusion criteria. Notably, the standard mean of overall severe adverse events was moderately high (SAEs: 9.10 ± 7.10%).

Conclusion

The population investigated is small and heterogeneous, published results from clinical trials are under-represented, severe adverse events not negligible, and cognitive outcomes uncertain. Overall, the validity of these studies requires confirmation based on forthcoming higher-quality clinical trials.

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Author notes

  1. Giulia Remoli and Leonardo Tariciotti share first authorship. Marco Locatelli and Nicola Vanacore share senior authorships.

Authors and Affiliations

  1. Neurology Section, School of Medicine and Surgery, Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy

    Giulia Remoli, Carlo Ferrarese & Ildebrando Appollonio

  2. Neurology Ward, San Gerardo Hospital, Monza, Italy

    Giulia Remoli, Fulvio Da Re, Carlo Ferrarese & Ildebrando Appollonio

  3. Unit of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

    Leonardo Tariciotti, Luigi Gianmaria Remore & Marco Locatelli

  4. University of Milan, Milan, Italy

    Leonardo Tariciotti & Luigi Gianmaria Remore

  5. Department of Neurosurgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA

    Paolo Palmisciano

  6. National Center for Disease Prevention and Health Promotion, Italian National Institute of Health, Rome, Italy

    Francesco Sciancalepore, Marco Canevelli, Eleonora Lacorte & Nicola Vanacore

  7. Department of Neuroscience, University of Rome “La Sapienza,”, Rome, Italy

    Marco Canevelli & Giuseppe Bruno

  8. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

    Marco Locatelli

  9. Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics, University of Milan, Milan, Italy

    Marco Locatelli

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  1. Giulia Remoli
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Contributions

Conceptualisation: G.R., L.T., N.V., E.L., F.S.; methodology: G.R., L.T., N.V.; formal analysis and investigation: G.R., L.T., P.M., F.S.; writing — original draft preparation: L.T., G.R.; writing — review and editing: I.A., C.F., F.D.R., M.C., E.L., G.B., M.L., N.V.; resources: N.V., M.L., I.A., C.F.; supervision: N.V., M.L.

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Correspondence to Leonardo Tariciotti.

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Remoli, G., Tariciotti, L., Remore, L.G. et al. An updated overview of recent and ongoing deep brain stimulation (DBS) trials in patients with dementia: a systematic review. Neurol Sci 44, 3395–3427 (2023). https://doi.org/10.1007/s10072-023-06821-w

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