Progressive Supranuclear PalsyNCT04237948
tDCS Plus Physical Therapy for Progressive Supranuclear Palsy
A study testing transcranial direct current stimulation (tDCS) and Physical therapy in people with Progressive Supranuclear Palsy and Parkinsonism, 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 cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology Design: Twenty probable PSP patients with no… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Progressive Supranuclear Palsy, Parkinsonism, Parkinsonian Disorders
- What is being tested?
- transcranial direct current stimulation (tDCS) and Physical therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 15 Dec 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: tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology
Objective of the study:
To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind 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 randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a ten cerebellar tDCS stimulations while the placebo arm will undergo sham stimulation.
Each patient will be evaluated before and after stimulation by PSP-rating scale (PSP-RS), cognitive tests and a battery of gait and movement tests 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 tDCS stimulation
Objective of the study:
To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a 10 days cerebellar tDCS stimulation while the placebo arm will undergo sham stimulation.
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum for ten days.
Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), cognitive assessment and a battery of gait and movement tests using wearing sensors technology.
Sensors assessment:
The following parameters will be evaluated before and after stimulation (real vs sham): The parameter for postural instability defined are:
- 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.
The parameter for gait and turning evaluation during normal walk and timed up and go, defined are: i) stealth length ii) step variability iii) step phases duration iv) gait speed v) turning velocity
- Being tested
- transcranial direct current stimulation (tDCS), Physical therapy
- Keywords
- tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy
- Medical subject headings
- Supranuclear Palsy, Progressive, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
Physical therapyBehavioural
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
| Study group | Role | What they receive |
|---|---|---|
| physical therapy plus REAL tDCS | Active comparator | Patients will be undergo a rehabilitation treatment during hospitalization consisting in 60 minutes of physical rehabilitation for 4 weeks.
Real Cerebellar tDCS will be applied for 10 days of time. Receives: Device: transcranial direct current stimulation (tDCS); Behavioral: Physical therapy |
| physical therapy plus SHAM tDCS | Placebo comparator | Patients will be undergo a rehabilitation treatment during hospitalization consisting in 60 minutes of physical rehabilitation for 4 weeks.
Sham Cerebellar tDCS will be applied for 10 days of time. Receives: Behavioral: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and after 3 months
Falls
Number of falls will be recorded using a diary
Measured: Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Cognitive testing
Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
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 (5)
Tinetti Balance test (TBT)
Assessment of postural instability (0-28, higher scores indicate better performances)
Measured: Changes from Baseline to immediately after stimulation and after 3 months
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
Gait speed
The speed of gait will be assessed in one minute of normal and dual-task walking
Measured: Changes from Baseline to immediately after stimulation
Turning speed
The velocity of turning will be assessed in timed up and go tests
Measured: Changes from Baseline to immediately after stimulation
Activity of daily living
the dependence of patient in ADL will be assessed with the help of caregiver
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 posted23 Jan 2020
- Study start1 Jan 2018
- Primary completion15 Nov 2019
- Study completion15 Dec 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
- Parallel groups
- Model description
- Two randomized double blind groups will be evaluated. Both group will undergo physical rehabilitation. The real arm group will undergo real cerebellar tDCS while the placebo-arm will undergo a sham 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
- Università degli Studi di Brescia, University of Kiel
- Responsible party
- Principal investigator, Andrea Pilotto, Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Investigators
- Andrea Pilotto, MD, Principal investigator, FERB onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237948
- Sponsor's protocol ID
- 19/02
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 23 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology
- ClinicalTrials.gov ID
- NCT04237948
- Acronym / sponsor ID
- 19/02
- Keywords
- tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Europea di Ricerca Biomedica Ferb OnlusUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, University of Kiel
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 23 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 cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a ten cerebellar tDCS stimulations while the placebo arm will undergo sham stimulation.
Each patient will be evaluated before and after stimulation by PSP-rating scale (PSP-RS), cognitive tests and a battery of gait and movement tests 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 tDCS stimulation
Objective of the study:
To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a 10 days cerebellar tDCS stimulation while the placebo arm will undergo sham stimulation.
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum for ten days.
Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), cognitive assessment and a battery of gait and movement tests using wearing sensors technology.
Sensors assessment:
The following parameters will be evaluated before and after stimulation (real vs sham): The parameter for postural instability defined are:
- 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.
The parameter for gait and turning evaluation during normal walk and timed up and go, defined are: i) stealth length ii) step variability iii) step phases duration iv) gait speed v) turning velocity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two randomized double blind groups will be evaluated. Both group will undergo physical rehabilitation. The real arm group will undergo real cerebellar tDCS while the placebo-arm will undergo a sham stimulation
| Arm | Type | Receives |
|---|---|---|
| physical therapy plus REAL tDCS | Active comparator | Device: transcranial direct current stimulation (tDCS), Behavioral: Physical therapyPatients will be undergo a rehabilitation treatment during hospitalization consisting in 60 minutes of physical rehabilitation for 4 weeks. Real Cerebellar tDCS will be applied for 10 days of time. |
| physical therapy plus SHAM tDCS | Placebo comparator | Behavioral: Physical therapyPatients will be undergo a rehabilitation treatment during hospitalization consisting in 60 minutes of physical rehabilitation for 4 weeks. Sham Cerebellar tDCS will be applied for 10 days of time. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 (1 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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum | Device | physical therapy plus REAL tDCS |
| Physical therapyHospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time | Behavioural | physical therapy plus REAL tDCS, physical therapy plus SHAM tDCS |
Primary outcome
PSP rating scale (PSP-RS)
Time frame: Changes from Baseline to immediately after stimulation and after 3 months
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Falls
Time frame: Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Number of falls will be recorded using a diary
Cognitive testing
Time frame: Changes from Baseline to immediately after stimulation
Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
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)
5 secondary outcomes
Tinetti Balance test (TBT)
Time frame: Changes from Baseline to immediately after stimulation and after 3 months
Static Balance: wearable sensor analyses - velocity
Time frame: Changes from Baseline to immediately after stimulation
Gait speed
Time frame: Changes from Baseline to immediately after stimulation
Turning speed
Time frame: Changes from Baseline to immediately after stimulation
Activity of daily living
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 23 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
FERB onlus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) and Physical therapy in people with Progressive Supranuclear Palsy and Parkinsonism, 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 1 inclusion and 1 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 23 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?
PSP rating scale (PSP-RS) (time frame: Changes from Baseline to immediately after stimulation and after 3 months). The study lists 4 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 23 Jan 2020.