NCT04237948

tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Progressive Supranuclear Palsy
• Parkinsonism
• Parkinsonian Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-11-15
• Completion: 2019-12-15
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: Italy