Clinical trial NCT04237948: 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
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Parkinsonism
Parkinsonian Disorders
Keywords: tDCS
transcranial direct current stimulation
falls
postural instability
wearing sensors
physical therapy
Lead sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
name: University of Kiel
First posted: 2020-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: PSP rating scale (PSP-RS)
timeFrame: Changes from Baseline to immediately after stimulation and after 3 months
measure: Falls
timeFrame: Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
measure: Cognitive testing
timeFrame: Changes from Baseline to immediately after stimulation
measure: Static Balance- area of sway
timeFrame: Changes from Baseline to immediately after stimulation
Secondary outcomes:
measure: Tinetti Balance test (TBT)
timeFrame: Changes from Baseline to immediately after stimulation and after 3 months
measure: Static Balance: wearable sensor analyses - velocity
timeFrame: Changes from Baseline to immediately after stimulation
measure: Gait speed
timeFrame: Changes from Baseline to immediately after stimulation
measure: Turning speed
timeFrame: Changes from Baseline to immediately after stimulation
measure: Activity of daily living
timeFrame: Changes from Baseline to immediately after stimulation
Other outcomes:
Locations:
city: Trescore Balneario
country: Italy
facility: Parkinson's disease Rehabilitation Centre - FERB ONLUS
Study officials:
affiliation: FERB onlus
name: Andrea Pilotto, MD
role: PRINCIPAL_INVESTIGATOR
References: