Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson’s disease: study protocol for a randomized controlled trial

Table 1 Detailed schedule of the RESTEP trial

Schedule	Baseline		Visit
Schedule	Screening	Upgrading	EG for VFS, CG for CFS	EG for VFS, CG for VFS	EG for VFS, CG for VFS
Time	3 ± 2 days	5 ± 2 days	90 ± 14 days	90 ± 14 days	180 ± 14 days
Follow-up	V1	V2	V3	V4	V5
Informed consent	X
Criteria for inclusion	X
Criteria for exclusion	X
MMSE	X		X		X
Hoehn-Yahr staging	X
Medical history/demographic data	X
Physical examination	X
Records of side effects	X	X	X		X
PDQ-39	X		X		X
FOG-Q	X		X		X
GAFQ	X		X		X
Medication	X		X		X
UPDRS (part I/II/IV)	X		X		X
Upgrade to dual mode		X
Random grouping		X
Programming	X	X	X	X	X
SWS test	X	X	X	X	X
UPDRS (part III)	X	X	X	X	X
Admission confirmed	X
AE		X	X	X	X
SAE		X	X	X	X

AE adverse event, CFS constant-frequency stimulation, CG control group, EG experimental group, FOG-Q Freezing of Gait Questionnaire, GAFQ Gait and Falls Questionnaire, MMSE Mini-Mental State Examination, PDQ-39 Parkinson’s Disease Questionnaire-39, SAE serious adverse event, SWS stand–walk–sit, UPDRS Unified Parkinson’s Disease Rating Scale, VFS variable-frequency stimulation

ISSN: 1745-6215