tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

NCT ID: NCT04237948

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-15

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

Conditions

Progressive Supranuclear Palsy; Parkinsonism; Parkinsonian Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum

Physical therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: PLACEBO_COMPARATOR

Physical therapy

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: DEVICE

Physical therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: collaborator

University of Kiel

OTHER

Sponsor Role: collaborator

Fondazione Europea di Ricerca Biomedica Ferb Onlus

OTHER

Sponsor Role: lead

Responsible Party

Andrea Pilotto

Parkinson's disease Rehabilitation Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Pilotto, MD

Role: PRINCIPAL_INVESTIGATOR

FERB onlus

Locations

Parkinson's disease Rehabilitation Centre - FERB ONLUS

Trescore Balneario, , Italy

Countries

Italy

Other Identifiers

19/02

Identifier Type: -

Identifier Source: org_study_id