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Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy (CerTI-PSP)

Primary Purpose

Progressive Supranuclear Palsy, Fall, Gait, Rigid

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
Fondazione Europea di Ricerca Biomedica Ferb Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring repetitive Transcranial Magnetic stimulation, cerebellum, wearing sensors, static balance

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkinson's disease Rehabilitation Centre - FERB ONLUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real Stimulation

Sham Stimulation

Arm 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.

The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation)

Outcomes

Primary Outcome Measures

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)
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
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.
Tinetti Balance test (TBT)
Assessment of postural instability (0-28, higher scores indicate better performances)
Static Balance- area of sway
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)

Secondary Outcome Measures

PSP rating scale (PSP-RS)
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Static Balance: wearable sensor analyses - velocity
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Static Balance: wearable sensor analyses - acceleration
the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)
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)

Full Information

First Posted
December 31, 2019
Last Updated
January 18, 2020
Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
University of Brescia, Neurology Department, University of Kiel, Neurogeriatric Department
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1. Study Identification

Unique Protocol Identification Number
NCT04222218
Brief Title
Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
University of Brescia, Neurology Department, University of Kiel, Neurogeriatric Department

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Fall, Gait, Rigid, Parkinsonism
Keywords
repetitive Transcranial Magnetic stimulation, cerebellum, wearing sensors, static balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
The patient and the examiner who administered the clinical scales were blind to the type of rTMS delivered, which was applied by another blinded experimenter.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real Stimulation
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation)
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS, theta Burst, rTMS
Intervention Description
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Primary Outcome Measure Information:
Title
Short Physical Performance Battery, total time (SPPB)
Description
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)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Timed up and Go tests, total time (TUG)
Description
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
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance tests, total time
Description
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.
Time Frame
Changes from Baseline to immediately after stimulation
Title
Tinetti Balance test (TBT)
Description
Assessment of postural instability (0-28, higher scores indicate better performances)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance- area of sway
Description
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Time Frame
Changes from Baseline to immediately after stimulation
Secondary Outcome Measure Information:
Title
PSP rating scale (PSP-RS)
Description
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance: wearable sensor analyses - velocity
Description
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance: wearable sensor analyses - acceleration
Description
the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance: wearable sensor analyses - jerk
Description
The time-derived of acceleration of sway will be assessed during the postural instability tasks (unit of measure mm3/s)
Time Frame
Changes from Baseline to immediately after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkinson's disease Rehabilitation Centre - FERB ONLUS
City
Trescore Balneario
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The whole project will be published in medical journal
IPD Sharing Time Frame
In the publication, within the next year
IPD Sharing Access Criteria
on-line availability

Learn more about this trial

Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

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