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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237948
Enrollment
20
Registered
2020-01-23
Start date
2018-01-01
Completion date
2019-12-15
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsonian Disorders, Parkinsonism, Progressive Supranuclear Palsy

Keywords

tDCS, transcranial direct current stimulation, falls, postural instability, wearing sensors, physical therapy

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

Interventions

DEVICEtranscranial 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

BEHAVIORALPhysical therapy

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

Sponsors

Università degli Studi di Brescia
CollaboratorOTHER
University of Kiel
CollaboratorOTHER
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

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.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PSP rating scale (PSP-RS)Changes from Baseline to immediately after stimulation and after 3 monthsAssessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
FallsNumber of falls recorded starting from immediately after stimulation until 3 months after the end of stimulationNumber of falls will be recorded using a diary
Cognitive testingChanges from Baseline to immediately after stimulationTotal Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
Static Balance- area of swayChanges from Baseline to immediately after stimulationThe area of sway during the postural instability tasks will be assessed (unit of measure mm2)

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026