tDCS Plus Physical Therapy for Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy; Parkinsonism; Parkinsonian Disorders
MeSH terms: Parkinsonian Disorders; Supranuclear Palsy, Progressive
Study type: Interventional

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
    

Intervention name(s): transcranial direct current stimulation (tDCS); Physical therapy
Intervention type(s): Device; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary purpose: Treatment
Keywords: tDCS; transcranial direct current stimulation; falls; postural instability; wearing sensors; physical therapy