Objective of the study: To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology Design: Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a ten cerebellar tDCS stimulations while the placebo arm will undergo sham stimulation. Each patient will be evaluated before and after stimulation by PSP-rating scale (PSP-RS), cognitive tests and a battery of gait and movement tests 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 tDCS stimulation Objective of the study: To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology Design: Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a 10 days cerebellar tDCS stimulation while the placebo arm will undergo sham stimulation. cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum for ten days. Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), cognitive assessment and a battery of gait and movement tests using wearing sensors technology. Sensors assessment: The following parameters will be evaluated before and after stimulation (real vs sham): The parameter for postural instability defined are: 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. The parameter for gait and turning evaluation during normal walk and timed up and go, defined are: i) stealth length ii) step variability iii) step phases duration iv) gait speed v) turning velocity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario, Italy
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 and after 3 months
Falls
Number of falls will be recorded using a diary
Time frame: Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Cognitive testing
Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
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
Tinetti Balance test (TBT)
Assessment of postural instability (0-28, higher scores indicate better performances)
Time frame: Changes from Baseline to immediately after stimulation and after 3 months
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
Gait speed
The speed of gait will be assessed in one minute of normal and dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
Turning speed
The velocity of turning will be assessed in timed up and go tests
Time frame: Changes from Baseline to immediately after stimulation
Activity of daily living
the dependence of patient in ADL will be assessed with the help of caregiver
Time frame: Changes from Baseline to immediately after stimulation
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