tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

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 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

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