Parkinson's disease Rehabilitation Centre - FERB ONLUS
Trescore Balneario, Italy
NCT Number: NCT04237948
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.
Looking for future studies?
Notify Me40 year–85 year
All sexes
Interventional
Not applicable
Trescore Balneario, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
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)
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
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)
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)
Time frame: Changes from Baseline to immediately after stimulation and after 3 months
Assessment of postural instability (0-28, higher scores indicate better performances)
Time frame: Changes from Baseline to immediately after stimulation
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Time frame: Changes from Baseline to immediately after stimulation
The speed of gait will be assessed in one minute of normal and dual-task walking
Time frame: Changes from Baseline to immediately after stimulation
The velocity of turning will be assessed in timed up and go tests
Time frame: Changes from Baseline to immediately after stimulation
the dependence of patient in ADL will be assessed with the help of caregiver
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Other
tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03924414
Atypical Parkinsonism, Autonomic Nervous System Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT04518059
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT04925622
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT04222218
Basal Ganglia Diseases, Brain Diseases
Trescore Balneario, Italy
View Trial Details