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] |