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

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

Access to Document

10.3390/jcm11030696Licence: CC BY

Cite this

@article{55dbb4a796df43388f13ff95cf50c572,

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",

note = "Publisher Copyright: {\textcopyright} 2022 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2022",

month = feb,

day = "1",

doi = "10.3390/jcm11030696",

language = "English",

volume = "11",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "3",

}

TY - JOUR

T1 - Methodological Considerations for Setting Up Deep Brain Stimulation Studies for New Indications

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.

PY - 2022/2/1

Y1 - 2022/2/1

N2 - 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.

AB - 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.

KW - deep brain stimulation

KW - first-in-human

KW - methodology

KW - feasibility

KW - safety

KW - PARKINSONS-DISEASE PATIENTS

KW - PATIENT SELECTION

KW - RANDOMIZED-TRIALS

KW - ESSENTIAL TREMOR

KW - NUCLEUS

KW - SURGERY

KW - PLACEBO

KW - ELECTRODE

KW - ETHICS

KW - EXPECTATION

U2 - 10.3390/jcm11030696

DO - 10.3390/jcm11030696

M3 - (Systematic) Review article

C2 - 35160153

SN - 2077-0383

VL - 11

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 3

M1 - 696

ER -