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