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tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

Primary Purpose

Progressive Supranuclear Palsy, Parkinsonism, Parkinsonian Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Physical therapy
Sponsored by
Fondazione Europea di Ricerca Biomedica Ferb Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkinson's disease Rehabilitation Centre - FERB ONLUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

physical therapy plus REAL tDCS

physical therapy plus SHAM tDCS

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2020
Last Updated
January 18, 2020
Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
Università degli Studi di Brescia, University of Kiel
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1. Study Identification

Unique Protocol Identification Number
NCT04237948
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Collaborators
Università degli Studi di Brescia, University of Kiel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Parkinsonism, Parkinsonian Disorders
Keywords
tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
The patient and the examiner who did the ratings were blind to the type of tDCS delivered, which was applied by another blinded experimenter.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical therapy plus REAL tDCS
Arm Type
Active Comparator
Arm 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.
Arm Title
physical therapy plus SHAM tDCS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Intervention Description
Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
Primary Outcome Measure Information:
Title
PSP rating scale (PSP-RS)
Description
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Time Frame
Changes from Baseline to immediately after stimulation and after 3 months
Title
Falls
Description
Number of falls will be recorded using a diary
Time Frame
Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Title
Cognitive testing
Description
Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Static Balance- area of sway
Description
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Time Frame
Changes from Baseline to immediately after stimulation
Secondary Outcome Measure Information:
Title
Tinetti Balance test (TBT)
Description
Assessment of postural instability (0-28, higher scores indicate better performances)
Time Frame
Changes from Baseline to immediately after stimulation and after 3 months
Title
Static Balance: wearable sensor analyses - velocity
Description
the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Time Frame
Changes from Baseline to immediately after stimulation
Title
Gait speed
Description
The speed of gait will be assessed in one minute of normal and dual-task walking
Time Frame
Changes from Baseline to immediately after stimulation
Title
Turning speed
Description
The velocity of turning will be assessed in timed up and go tests
Time Frame
Changes from Baseline to immediately after stimulation
Title
Activity of daily living
Description
the dependence of patient in ADL will be assessed with the help of caregiver
Time Frame
Changes from Baseline to immediately after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Organizational Affiliation
FERB onlus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkinson's disease Rehabilitation Centre - FERB ONLUS
City
Trescore Balneario
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

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