Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

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Brief Title

Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

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

Brief 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.
    


Study Type

Interventional


Primary Outcome

Short Physical Performance Battery, total time (SPPB)

Secondary Outcome

 PSP rating scale (PSP-RS)

Condition

Progressive Supranuclear Palsy

Intervention

repetitive transcranial magnetic stimulation

Study Arms / Comparison Groups

 Real Stimulation
Description:  Cerebellar Repetitive theta burst stimulation will be performed 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

June 1, 2017

Completion Date

November 15, 2019

Primary Completion Date

November 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  probable PSP diagnosis

          -  ability to stand alone without support for at least 5 seconds

          -  ability to walk without aid for at least three meters

        Exclusion Criteria:

          -  dementia or behavioral alterations

          -  contraindications of stimulation
      

Gender

All

Ages

40 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Andrea Pilotto, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04222218

Organization ID

191201


Responsible Party

Principal Investigator

Study Sponsor

Fondazione Europea di Ricerca Biomedica Ferb Onlus

Collaborators

 University of Brescia, Neurology Department

Study Sponsor

Andrea Pilotto, MD, Principal Investigator, Università degli Studi di Brescia


Verification Date

January 2020