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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario, Italy
Short Physical Performance Battery, total time (SPPB)
The short Physical performance battery included a walking test at convenient speed, a chair-rise test at convenient speed and tests of static balance including feet together, semi-tandem and tandem stance)
Time frame: Changes from Baseline to immediately after stimulation
Timed up and Go tests, total time (TUG)
The time of performance of two timed up and go test ( one starting with the right foot, one starting with the left foot) will be assessed
Time frame: Changes from Baseline to immediately after stimulation
Static Balance tests, total time
The assessment of static balance will include four tasks, in which the patient has to stand alone and maintain the position in different conditions for up to 30 seconds: tandem and semitandem positions with eyes closed and eyes open, respectively. The time of performance without falling will be assessed.
Time frame: Changes from Baseline to immediately after stimulation
Tinetti Balance test (TBT)
Assessment of postural instability (0-28, higher scores indicate better performances)
Time frame: Changes from Baseline to immediately after stimulation
Static Balance- area of sway
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Time frame: Changes from Baseline to immediately after stimulation
PSP rating scale (PSP-RS)
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - velocity
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - acceleration
the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - jerk
The time-derived of acceleration of sway will be assessed during the postural instability tasks (unit of measure mm3/s)
Time frame: Changes from Baseline to immediately after stimulation
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