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Completed

NCT Number: NCT04237948

tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

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.

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Key information

About this study

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

Who can participate

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum

Physical Therapy

Behavioral

Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time

Primary outcomes

  1. PSP rating scale (PSP-RS)

    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)

  2. Falls

    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

  3. Cognitive testing

    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)

  4. Static Balance- area of sway

    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)

Secondary outcomes

  1. Tinetti Balance test (TBT)

    Time frame: Changes from Baseline to immediately after stimulation and after 3 months

    Assessment of postural instability (0-28, higher scores indicate better performances)

  2. Static Balance: wearable sensor analyses - velocity

    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)

  3. Gait speed

    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

  4. Turning speed

    Time frame: Changes from Baseline to immediately after stimulation

    The velocity of turning will be assessed in timed up and go tests

  5. Activity of daily living

    Time frame: Changes from Baseline to immediately after stimulation

    the dependence of patient in ADL will be assessed with the help of caregiver

Sponsors and collaborators

Lead sponsor

Fondazione Europea di Ricerca Biomedica Ferb Onlus

Other

Collaborators

  • University of Kiel
  • Università degli Studi di Brescia

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

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.

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