Methodological Considerations for Setting Up Deep Brain Stimulation Studies for New Indications

J.V.P. Devos; Y. Temel; L. Ackermans; V. Visser-Vandewalle; O.A. Onur; K. Schruers; J. Smit; M.L.F. Janssen

doi:10.3390/jcm11030696

Methodological Considerations for Setting Up Deep Brain Stimulation Studies for New Indications

J.V.P. Devos^*, Y. Temel^*, L. Ackermans, V. Visser-Vandewalle, O.A. Onur, K. Schruers, J. Smit, M.L.F. Janssen

^*Corresponding author for this work

Research output: Contribution to journal › (Systematic) Review article › peer-review

1 Citation (Web of Science)

Abstract

Deep brain stimulation (DBS) is a neurosurgical treatment with a growing range of indications. The number of clinical studies is expanding because of DBS for new indications and efforts to improve DBS for existing indications. To date, various methods have been used to perform DBS studies. Designing a clinical intervention study with active implantable medical devices has specific challenges while expanding patient treatment. This paper provides an overview of the key aspects that are essential for setting up a DBS study.

Original language	English
Article number	696
Number of pages	14
Journal	Journal of Clinical Medicine
Volume	11
Issue number	3
DOIs	https://doi.org/10.3390/jcm11030696
Publication status	Published - 1 Feb 2022

Keywords

deep brain stimulation
first-in-human
methodology
feasibility
safety
PARKINSONS-DISEASE PATIENTS
PATIENT SELECTION
RANDOMIZED-TRIALS
ESSENTIAL TREMOR
NUCLEUS
SURGERY
PLACEBO
ELECTRODE
ETHICS
EXPECTATION

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10.3390/jcm11030696Licence: CC BY-NC

Cite this

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title = "Methodological Considerations for Setting Up Deep Brain Stimulation Studies for New Indications",

abstract = "Deep brain stimulation (DBS) is a neurosurgical treatment with a growing range of indications. The number of clinical studies is expanding because of DBS for new indications and efforts to improve DBS for existing indications. To date, various methods have been used to perform DBS studies. Designing a clinical intervention study with active implantable medical devices has specific challenges while expanding patient treatment. This paper provides an overview of the key aspects that are essential for setting up a DBS study.",

keywords = "deep brain stimulation, first-in-human, methodology, feasibility, safety, PARKINSONS-DISEASE PATIENTS, PATIENT SELECTION, RANDOMIZED-TRIALS, ESSENTIAL TREMOR, NUCLEUS, SURGERY, PLACEBO, ELECTRODE, ETHICS, EXPECTATION",

author = "J.V.P. Devos and Y. Temel and L. Ackermans and V. Visser-Vandewalle and O.A. Onur and K. Schruers and J. Smit and M.L.F. Janssen",

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AU - Devos, J.V.P.

AU - Temel, Y.

AU - Ackermans, L.

AU - Visser-Vandewalle, V.

AU - Onur, O.A.

AU - Schruers, K.

AU - Smit, J.

AU - Janssen, M.L.F.

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KW - first-in-human

KW - methodology

KW - feasibility

KW - safety

KW - PARKINSONS-DISEASE PATIENTS

KW - PATIENT SELECTION

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KW - ESSENTIAL TREMOR

KW - NUCLEUS

KW - SURGERY

KW - PLACEBO

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KW - ETHICS

KW - EXPECTATION

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