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Completed

NCT Number: NCT04222218

Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

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.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Fall Gait Disorders, Neurologic Gait, Rigid Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinsonian Disorders Parkinsonism Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkinson's disease Rehabilitation Centre - FERB ONLUS

Trescore Balneario, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Other names: rTMS, theta Burst, rTMS

Primary outcomes

  1. Short Physical Performance Battery, total time (SPPB)

    Time frame: Changes from Baseline to immediately after stimulation

    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)

  2. Timed up and Go tests, total time (TUG)

    Time frame: Changes from Baseline to immediately after stimulation

    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

  3. Static Balance tests, total time

    Time frame: Changes from Baseline to immediately after stimulation

    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.

  4. Tinetti Balance test (TBT)

    Time frame: Changes from Baseline to immediately after stimulation

    Assessment of postural instability (0-28, higher scores indicate better performances)

  5. Static Balance- area of sway

    Time frame: Changes from Baseline to immediately after stimulation

    The area of sway during the postural instability tasks will be assessed (unit of measure mm2)

Secondary outcomes

  1. PSP rating scale (PSP-RS)

    Time frame: Changes from Baseline to immediately after stimulation

    Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)

  2. Static Balance: wearable sensor analyses - velocity

    Time frame: Changes from Baseline to immediately after stimulation

    the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)

  3. Static Balance: wearable sensor analyses - acceleration

    Time frame: Changes from Baseline to immediately after stimulation

    the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)

  4. Static Balance: wearable sensor analyses - jerk

    Time frame: Changes from Baseline to immediately after stimulation

    The time-derived of acceleration of sway will be assessed during the postural instability tasks (unit of measure mm3/s)

Sponsors and collaborators

Lead sponsor

Fondazione Europea di Ricerca Biomedica Ferb Onlus

Other

Collaborators

  • University of Brescia, Neurology Department
  • University of Kiel

Registry information

Official study title

Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy: a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology

Acronym: CerTI-PSP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2020
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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