tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

Study Overview
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Brief Summary
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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
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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

Official Title
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tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology

Conditions
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Progressive Supranuclear Palsy, Parkinsonism, Parkinsonian Disorders

Intervention / Treatment
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* Device: transcranial direct current stimulation (tDCS)
* Behavioral: Physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: physical therapy plus REAL tDCS<br>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. | Device: transcranial direct current stimulation (tDCS)<br>* cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum<br>Behavioral: Physical therapy<br>* Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time<br>|
| Placebo Comparator: physical therapy plus SHAM tDCS<br>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. | Behavioral: Physical therapy<br>* Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy