Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy; Fall; Gait, Rigid; Parkinsonism
MeSH terms: Parkinsonian Disorders; Supranuclear Palsy, Progressive; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Other intervention name(s): rTMS; theta Burst, rTMS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each patient received both rTMS and sham cerebellar stimulation in randomized order in two different sessions, separated by at least 2 weeks. In each session, motor tasks, clinical scales and wearing sensor assessments were tested twice in all patients: at baseline (pre-stimulation) and after rTMS (post-stimulation)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: repetitive Transcranial Magnetic stimulation; cerebellum; wearing sensors; static balance