tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

NCT04237948 | Completed

• 1 other identifier: 19/02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Supranuclear Palsy; Parkinsonism; Parkinsonian Disorders

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Tinetti Balance test (TBT)

  Changes from Baseline to immediately after stimulation and after 3 months

• Static Balance: wearable sensor analyses - velocity

  Changes from Baseline to immediately after stimulation

• Gait speed

  Changes from Baseline to immediately after stimulation

• Turning speed

  Changes from Baseline to immediately after stimulation

• Activity of daily living

  Changes from Baseline to immediately after stimulation

Study Arms (2)

physical therapy plus REAL tDCS

ACTIVE COMPARATOR

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.

Device: transcranial direct current stimulation (tDCS); Behavioral: Physical therapy

physical therapy plus SHAM tDCS

PLACEBO COMPARATOR

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.

Behavioral: Physical therapy

Interventions

transcranial direct current stimulation (tDCS) 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 plus REAL tDCS

Physical therapy BEHAVIORAL

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

physical therapy plus REAL tDCS; physical therapy plus SHAM tDCS

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• probable PSP diagnosis ability to stand alone without support for at least 5 seconds ability to walk without aid for at least three meters

You may not qualify if:

• dementia or behavioral alterations contraindications of stimulation

Sponsors & Collaborators

• Fondazione Europea di Ricerca Biomedica Ferb Onlus: lead
• Università degli Studi di Brescia: collaborator
• University of Kiel: collaborator

Study Sites (1)

Parkinson's disease Rehabilitation Centre - FERB ONLUS

Trescore Balneario, Italy

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Parkinsonian Disorders

Interventions

Transcranial Direct Current Stimulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation

Study Officials

• Andrea Pilotto, MD

  FERB onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and the examiner who did the ratings were blind to the type of tDCS delivered, which was applied by another blinded experimenter.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Parkinson's disease Rehabilitation Centre

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: January 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: December 15, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: In the publication, within the next year
• Access Criteria: on-line free access

Locations

IT (1)