Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

Fall Clinical Trial

— CerTI-PSP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222218
• Other study ID #: 191201
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: November 15, 2019

Study information

• Verified date: January 2020
• Source: Fondazione Europea di Ricerca Biomedica Ferb Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Gait Disorders, Neurologic
• Gait, Rigid
• Parkinsonian Disorders
• Parkinsonism
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Device:
• repetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Locations

Country	Name	City	State
Italy	Parkinson's disease Rehabilitation Centre - FERB ONLUS	Trescore Balneario

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Europea di Ricerca Biomedica Ferb Onlus	University of Brescia, Neurology Department, University of Kiel, Neurogeriatric Department

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Changes from Baseline to immediately after stimulation
Primary	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	Changes from Baseline to immediately after stimulation
Primary	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.	Changes from Baseline to immediately after stimulation
Primary	Tinetti Balance test (TBT)	Assessment of postural instability (0-28, higher scores indicate better performances)	Changes from Baseline to immediately after stimulation
Primary	Static Balance- area of sway	The area of sway during the postural instability tasks will be assessed (unit of measure mm2)	Changes from Baseline to immediately after stimulation
Secondary	PSP rating scale (PSP-RS)	Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)	Changes from Baseline to immediately after stimulation
Secondary	Static Balance: wearable sensor analyses - velocity	the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)	Changes from Baseline to immediately after stimulation
Secondary	Static Balance: wearable sensor analyses - acceleration	the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)	Changes from Baseline to immediately after stimulation
Secondary	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)	Changes from Baseline to immediately after stimulation