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

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.

Study Overview

• Status: Completed
• Conditions: Parkinsonian Disorders; Parkinsonism; Progressive Supranuclear Palsy
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS); Behavioral: Physical therapy

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trescore Balneario, Italy
    • Parkinson's disease Rehabilitation Centre - FERB ONLUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: physical therapy plus REAL tDCS; 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.	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
PLACEBO_COMPARATOR: physical therapy plus SHAM tDCS; Patients will be undergo a rehabilitation treatment during hospitalization consisting in 60 minutes of physical rehabilitation for 4 weeks. Sham Cerebellar tDCS will be applied for 10 days of time.	Behavioral: Physical therapy; Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Balance- area of sway	The area of sway during the postural instability tasks will be assessed (unit of measure mm2)	Changes from Baseline to immediately after stimulation
PSP rating scale (PSP-RS)	Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)	Changes from Baseline to immediately after stimulation and after 3 months
Falls	Number of falls will be recorded using a diary	Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Cognitive testing	Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)	Changes from Baseline to immediately after stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Balance: wearable sensor analyses - velocity	the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)	Changes from Baseline to immediately after stimulation
Tinetti Balance test (TBT)	Assessment of postural instability (0-28, higher scores indicate better performances)	Changes from Baseline to immediately after stimulation and after 3 months
Gait speed	The speed of gait will be assessed in one minute of normal and dual-task walking	Changes from Baseline to immediately after stimulation
Turning speed	The velocity of turning will be assessed in timed up and go tests	Changes from Baseline to immediately after stimulation
Activity of daily living	the dependence of patient in ADL will be assessed with the help of caregiver	Changes from Baseline to immediately after stimulation

Collaborators and Investigators

• Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus
• Collaborators: University of Kiel; Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): November 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 18, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 18, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: tDCS; transcranial direct current stimulation; falls; physical therapy; wearing sensors; postural instability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Paralysis; Ophthalmoplegia; Parkinsonian Disorders; Supranuclear Palsy, Progressive
• Other Study ID Numbers: 19/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The whole project will be published in medical journal
• IPD Sharing Time Frame: In the publication, within the next year
• IPD Sharing Access Criteria: on-line free access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No