Progressive Supranuclear PalsyCerTI-PSPNCT04222218
Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy
A study testing repetitive transcranial magnetic stimulation in people with Progressive Supranuclear Palsy and Fall, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Fall, Gait, Rigid
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- probable PSP diagnosis
- ability to stand alone without support for at least 5 seconds
- ability to walk without aid for at least three meters
Who cannot join
- dementia or behavioral alterations
- contraindications of stimulation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario
About this study
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
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
Read more
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.
Read the 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.
- Conditions
- Progressive Supranuclear Palsy, Fall, Gait, Rigid, Parkinsonism
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- repetitive Transcranial Magnetic stimulation, cerebellum, wearing sensors, static balance
- Medical subject headings
- Supranuclear Palsy, Progressive, Gait Disorders, Neurologic, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Also called rTMS, theta Burst, rTMS
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | 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. Receives: Device: repetitive transcranial magnetic stimulation |
| Sham Stimulation | Sham comparator | 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) Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Changes from Baseline to immediately after stimulation
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
Measured: Changes from Baseline to immediately after stimulation
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.
Measured: Changes from Baseline to immediately after stimulation
Tinetti Balance test (TBT)
Assessment of postural instability (0-28, higher scores indicate better performances)
Measured: Changes from Baseline to immediately after stimulation
Static Balance- area of sway
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Measured: Changes from Baseline to immediately after stimulation
Secondary outcomes (4)
PSP rating scale (PSP-RS)
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Measured: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - velocity
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Measured: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - acceleration
the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)
Measured: Changes from Baseline to immediately after stimulation
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)
Measured: Changes from Baseline to immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Jun 2017
- Primary completion1 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brescia, Neurology Department, University of Kiel
- Responsible party
- Principal investigator, Andrea Pilotto, Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Investigators
- Andrea Pilotto, MD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222218
- Sponsor's protocol ID
- 191201
- Acronym
- CerTI-PSP
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole project will be published in medical journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04222218
- Acronym / sponsor ID
- CerTI-PSP / 191201
- Conditions
- Progressive Supranuclear Palsy, Fall, Gait, Rigid, Parkinsonism
- Keywords
- repetitive Transcranial Magnetic stimulation, cerebellum, wearing sensors, static balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb OnlusUniversity, hospital or other
- Collaborators
- University of Brescia, Neurology Department, University of Kiel
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: repetitive transcranial magnetic stimulationCerebellar 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. |
| Sham Stimulation | Sham comparator | Device: repetitive transcranial magnetic stimulationThe 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) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- probable PSP diagnosis
- ability to stand alone without support for at least 5 seconds
- ability to walk without aid for at least three meters
Key exclusion criteria (2 listed)
- dementia or behavioral alterations
- contraindications of stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: rTMS, theta Burst, rTMSCerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description | Device | Real Stimulation, Sham Stimulation |
Primary outcome
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)
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
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.
Tinetti Balance test (TBT)
Time frame: Changes from Baseline to immediately after stimulation
Assessment of postural instability (0-28, higher scores indicate better performances)
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)
4 secondary outcomes
PSP rating scale (PSP-RS)
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - velocity
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - acceleration
Time frame: Changes from Baseline to immediately after stimulation
Static Balance: wearable sensor analyses - jerk
Time frame: Changes from Baseline to immediately after stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Yes. The whole project will be published in medical journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Pilotto, MD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Progressive Supranuclear Palsy and Fall, run by Fondazione Europea di Ricerca Biomedica Ferb Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery, total time (SPPB) (time frame: Changes from Baseline to immediately after stimulation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.