Table 2.

List and distribution of adverse events

Adverse Events	Early start (n = 6)	Delayed start (n = 6)	Pilots (n = 2)	Consequence
Procedural AEs
Dural puncture	1	0	0	Reoperation (n = 1)
Lead misplacement	2	0	0	Reoperation (n = 2)
Peri-operative pain	1	0	0	Inpatient additional day (n = 1)
Oedema/swelling over the implantation site	3	2	0	Self-limited (n = 5)
Peri-surgical increase in Parkinsonian symptoms	3	6	0	Self-limited (n = 9)
AEs during the trial period
Falls requiring hospital contact	1 (One fall during RCT, one during open phase)	1 (One fall during RCT, one during open phase)	1	Two fractures of the proximal humerus (Early start) One Colles fracture (Pilots)

AEs: Adverse events. RCT: Randomised controlled trial. n: number of individuals.