Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Università degli Studi di Brescia | OTHER |
| University of Kiel | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and after 3 months |
| Falls | Number of falls will be recorded using a diary | 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) | 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) | Changes from Baseline to immediately after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Tinetti Balance test (TBT) | Assessment of postural instability (0-28, higher scores indicate better performances) | Changes from Baseline to immediately after stimulation and after 3 months |
| Static Balance: wearable sensor analyses - velocity |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Pilotto, MD | FERB onlus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's disease Rehabilitation Centre - FERB ONLUS | Trescore Balneario | Italy |
The whole project will be published in medical journal
In the publication, within the next year
on-line free access
Not provided
Not provided
| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
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
Not provided
Not provided
The patient and the examiner who did the ratings were blind to the type of tDCS delivered, which was applied by another blinded experimenter.
| Physical therapy | Behavioral | Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time |
|
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
| 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 | Changes from Baseline to immediately after stimulation |
| Turning speed | The velocity of turning will be assessed in timed up and go tests | 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 | Changes from Baseline to immediately after stimulation |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012046 | Rehabilitation |