tDCS Plus Physical Therapy for Progressive Supranuclear Palsy
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
- 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: physical therapy plus REAL tDCS 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)
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
Behavioral: Physical therapy
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
|
| Placebo Comparator: physical therapy plus SHAM tDCS 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
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
|
Outcome Measures
Primary Outcome Measures
- PSP rating scale (PSP-RS) [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 [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 [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 [Changes from Baseline to immediately after stimulation]
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Secondary Outcome Measures
- Tinetti Balance test (TBT) [Changes from Baseline to immediately after stimulation and after 3 months]
Assessment of postural instability (0-28, higher scores indicate better performances)
- Static Balance: wearable sensor analyses - velocity [Changes from Baseline to immediately after stimulation]
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
- Gait speed [Changes from Baseline to immediately after stimulation]
The speed of gait will be assessed in one minute of normal and dual-task walking
- Turning speed [Changes from Baseline to immediately after stimulation]
The velocity of turning will be assessed in timed up and go tests
- Activity of daily living [Changes from Baseline to immediately after stimulation]
the dependence of patient in ADL will be assessed with the help of caregiver
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parkinson's disease Rehabilitation Centre - FERB ONLUS | Trescore Balneario | Italy |
Sponsors and Collaborators
- Fondazione Europea di Ricerca Biomedica Ferb Onlus
- Università degli Studi di Brescia
- University of Kiel
Investigators
- Principal Investigator: Andrea Pilotto, MD, FERB onlus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19/02