Fall Clinical Trial
Official title:
Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy: 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 postural instability in
progressive supranuclear palsy using a cross-over design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk 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 berg balance tests (BBS),
Tinetti scale, PSP-rating scale (PSP-RS), and a battery of gait and movement tests.
Static balance was assessed by 30-seconds-trials in semitandem and tandem positions with eyes
open and closed using wearing sensors technology.
Background:
There are no medical effective treatments for progressive supranuclear palsy (PSP). Imaging,
neurophysiology and pathology studies suggested cerebellum as possible target of brain
stimulation for postural instability using theta Burst repetitive Transcranial magnetic
stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on postural instability in
progressive supranuclear palsy using a cross-over design and wearing sensors technology
Design:
Probable PSP 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 berg balance tests (BBS),
Tinetti scale, PSP-rating scale (PSP-RS), and a battery of gait and movement tests.
Static balance was assessed by 30-seconds-trials in semitandem and tandem positions with eyes
open and closed using wearing sensors technology.
Sensors assessment:
The following parameters will be evaluated before and after stimulation (real vs sham): The
parameter i) TIME, defined as time without falling ii) The parameter "surface", defined as
the sway area iii) Velocity describes the mean velocity of the compensatory movements given
in mm/s. iv) Acceleration described as root mean square (RMS), v) Jerk, the time derivate of
acceleration, quantifies smoothness of the compensatory movements given in mG/s.
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