Parkinson Disease Clinical Trial
Official title:
Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease:a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on dual task walking in
Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over
sham-controlled study. Each patient will undergo a sham stimulation or a single session of
cerebellar theta burst stimulation with a wash out period of at least 14 days.
Each patient will be evaluated before and after stimulation by a battery of gait and movement
tests using wearing sensors technology .
There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging,
neurophysiology and pathology studies suggested cerebellum as possible target of brain
stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic
stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease
using a cross-over design and wearing sensors technology
Design:
Parkinson's disease patients able to walk and without dementia/behavioral disturbances will
be recruited for a cross-over sham-controlled study. Each patient will undergo a sham
stimulation or a single session of cerebellar theta burst stimulation with a wash out period
of at least 14 days.
Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, using a 3
pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals
for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor
Threshold (RMT) obtained in the left motor cortex for each subject.
A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a
total number of stimulation)
Each patient will be evaluated before and after stimulation by a battery of gait and movement
tests using wearing sensors technology.
Sensors assessment:
The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks:
i) step length ii) step variability iii) step phases iv) turning speed
;
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