Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential efficacy of the treatment. In this study the investigators aimed to explore the safety and efficacy of excitatory rTMS with H-coil on PD motor symptoms.
This was a double-blind, placebo-controlled study, with a 1:1:1 randomization into three groups: group 1 - real rTMS over primary motor cortex and prefrontal cortex (M1-PFC): group 2 - real rTMS over M1 and sham rTMS over PFC; group 3 - sham stimulation over both targets
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
IRCCS San Raffaele
Milan, MI, Italy
Change at Unified Parkinson's disease rating scale III over time
A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
monitoring presence of side effects due to the stimulation
Time frame: End of treatment (1 month after start of the treatment)
Change at Pegboard test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Tapping test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Up & Go Test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at dyskinesia rating scale over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at and at Word Fluency test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
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Change at Digit forward & backward test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Beck Depression Inventory scale-II over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at The Clinical Global Impression - Severity scale ( CGI-S) over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)