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

被引：1

作者：

Devos, Jana V. P. ^{[1
,2
]}

Temel, Yasin ^{[1
,3
]}

Ackermans, Linda ^{[1
,3
]}

Visser-Vandewalle, Veerle ^{[4
,5
]}

Onur, Oezguer A. ^{[6
,7
]}

Schruers, Koen ^{[8
]}

Smit, Jasper ^{[1
,9
]}

Janssen, Marcus L. F. ^{[1
,10
]}

机构：

[1] Maastricht Univ, Sch Mental Hlth & Neurosci, NL-6229 ER Maastricht, Netherlands

[2] Maastricht Univ, Med Ctr, Dept Ear Nose Throat Head & Neck Surg, NL-6229 HX Maastricht, Netherlands

[3] Maastricht Univ, Med Ctr, Dept Neurosurg, NL-6229 HX Maastricht, Netherlands

[4] Univ Cologne, Dept Stereotact & Funct Neurosurg, Fac Med, D-50923 Cologne, Germany

[5] Univ Cologne, Univ Hosp Cologne, D-50923 Cologne, Germany

[6] Univ Cologne, Fac Med, Dept Neurol, D-50923 Cologne, Germany

[7] Univ Cologne, Univ Hosp Cologne, D-50923 Cologne, Germany

[8] Maastricht Univ, Med Ctr, Dept Psychiat & Neuropsychol, NL-6229 HX Maastricht, Netherlands

[9] Zuyderland Med Ctr, Dept Ear Nose Throat Head & Neck Surg, NL-6419 PC Heerlen, Netherlands

[10] Maastricht Univ, Med Ctr, Dept Clin Neurophysiol, NL-6229 HX Maastricht, Netherlands

来源：

JOURNAL OF CLINICAL MEDICINE | 2022年 / 11卷 / 03期

关键词：

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

D O I：

10.3390/jcm11030696

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：14

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