Brief Title
tDCS Plus Physical Therapy for Progressive Supranuclear Palsy
Official Title
tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology
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.
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: 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
Study Type
Interventional
Primary Outcome
PSP rating scale (PSP-RS)
Secondary Outcome
Tinetti Balance test (TBT)
Condition
Progressive Supranuclear Palsy
Intervention
transcranial direct current stimulation (tDCS)
Study Arms / Comparison Groups
physical therapy plus REAL tDCS
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
January 1, 2018
Completion Date
December 15, 2019
Primary Completion Date
November 15, 2019
Eligibility 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
Gender
All
Ages
40 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Andrea Pilotto, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04237948
Organization ID
19/02
Responsible Party
Principal Investigator
Study Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
Università degli Studi di Brescia
Study Sponsor
Andrea Pilotto, MD, Principal Investigator, FERB onlus
Verification Date
January 2020