tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

Progressive Supranuclear Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237948
• Other study ID #: 19/02
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2020
• Source: Fondazione Europea di Ricerca Biomedica Ferb Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinsonian Disorders
• Parkinsonism
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

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

Locations

Country	Name	City	State
Italy	Parkinson's disease Rehabilitation Centre - FERB ONLUS	Trescore Balneario

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Europea di Ricerca Biomedica Ferb Onlus	Università degli Studi di Brescia, University of Kiel

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Turning speed	The velocity of turning will be assessed in timed up and go tests	Changes from Baseline to immediately after stimulation
Secondary	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