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Table 1 Known and unknown physical risks of DBS for AD

From: Opening the debate on deep brain stimulation for Alzheimer disease – a critical evaluation of rationale, shortcomings, and ethical justification

 

Risk [brain target:], percent range depending on source

Degree of evidence

First author, year, reference

General risks

of device implantation

Hemorrhage (1.1–2.5%),

Indirect evidence from other indications, not directly translatable to new indications like AD.

Ponce, 2016, [103]

Binder, 2003, [104]

Fenoy, 2014, [105]

Sillay, 2008, [106]

Wang, 2017, [107]

Voon, 2008, [108]

Chhabra, 2010, [109]

Morishita, 2013, [110]

Saleh, 2015, [111]

Wound infection (1.7–8%),

Hardware failure (1.5–36%),

Suicide (0.5%)

Encephalomalacia (4.2%)

Venous thrombosis (1.3%)

Special risks

of stimulation or device implantation in brain tissue with AD pathophysiology

Fornix: Infection (4.8%), lead repositioning (2.4%), chronic subdural hematoma (2.4%), encephalomalacia (2.4%)

Preliminary evidence from serial case studies (NBM and VC/VS) or small trials (fornix).

Limited by the lack of sufficient statistical power to detect adverse effects that are not extremely common; no extrapolation possible in scientific valid ways.

Ponce, 2016, [103]

McMullen, 2016, [112]

Kuhn, 2015 [15]

Scharre, 2016, [20]

NBM: hardware malfunctioning requiring surgical revision (33%)

VC/VS: no adverse events reported

Side effects

limiting the range of possible stimulation parameters to find beneficial physiological effects

Fornix: autonomic and cardiovascular effects including sensations of warmth and increases in heart rate and blood pressure (at high stimulation settings)

Ponce, 2016, [103]

NBM: Transient inner restlessness at higher stimulation intensities of > 5 Volt

Kuhn, 2015 [15]

  1. Definitions: An ‘adverse effect’ is an “unfavorable outcome that occurs during or after the use of a drug or other intervention but is not necessarily caused by it” [39]. A ‘side effect’ is any “unintended effect, adverse or beneficial, of a drug that occurs at doses normally used for treatment” [39]