Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy

NCT04222218 | Completed

• 1 other identifier: 191201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of the study: To test the efficacy of theta burst cerebellar stimulation on postural instability in progressive supranuclear palsy using a cross-over design and wearing sensors technology Design: Twenty probable PSP patients with no dementia and still able to walk will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days. Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), and a battery of gait and movement tests. Static balance was assessed by 30-seconds-trials in semitandem and tandem positions with eyes open and closed using wearing sensors technology.

Conditions

Progressive Supranuclear Palsy; Fall; Gait, Rigid; Parkinsonism

Keywords

repetitive Transcranial Magnetic stimulation; cerebellum; wearing sensors; static balance

Outcome Measures

Primary Outcomes (5)

• Short Physical Performance Battery, total time (SPPB)

  The short Physical performance battery included a walking test at convenient speed, a chair-rise test at convenient speed and tests of static balance including feet together, semi-tandem and tandem stance)

  Changes from Baseline to immediately after stimulation

• Timed up and Go tests, total time (TUG)

  The time of performance of two timed up and go test ( one starting with the right foot, one starting with the left foot) will be assessed

  Changes from Baseline to immediately after stimulation

• Static Balance tests, total time

  The assessment of static balance will include four tasks, in which the patient has to stand alone and maintain the position in different conditions for up to 30 seconds: tandem and semitandem positions with eyes closed and eyes open, respectively. The time of performance without falling will be assessed.

  Changes from Baseline to immediately after stimulation

• Tinetti Balance test (TBT)

  Assessment of postural instability (0-28, higher scores indicate better performances)

  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 (4)

• PSP rating scale (PSP-RS)

  Changes from Baseline to immediately after stimulation

• Static Balance: wearable sensor analyses - velocity

  Changes from Baseline to immediately after stimulation

• Static Balance: wearable sensor analyses - acceleration

  Changes from Baseline to immediately after stimulation

• Static Balance: wearable sensor analyses - jerk

  Changes from Baseline to immediately after stimulation

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

Cerebellar Repetitive theta burst stimulation will be performed using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.

Device: repetitive transcranial magnetic stimulation

Sham Stimulation

SHAM COMPARATOR

The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation)

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Also known as: rTMS, theta Burst, rTMS

Real Stimulation; Sham Stimulation

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
• University of Brescia, Neurology Department: collaborator
• University of Kiel, Neurogeriatric Department: collaborator

Study Sites (1)

Parkinson's disease Rehabilitation Centre - FERB ONLUS

Trescore Balneario, Italy

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Gait Disorders, Neurologic; Parkinsonian Disorders

Interventions

Transcranial Magnetic Stimulation

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)

Magnetic Field Therapy; Therapeutics

Study Officials

• Andrea Pilotto, MD

  Università degli Studi di Brescia

  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 administered the clinical scales were blind to the type of rTMS delivered, which was applied by another blinded experimenter.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: parkinson's disease Rehabilitation Centre

Model Details: Each patient received both rTMS and sham cerebellar stimulation in randomized order in two different sessions, separated by at least 2 weeks. In each session, motor tasks, clinical scales and wearing sensor assessments were tested twice in all patients: at baseline (pre-stimulation) and after rTMS (post-stimulation)

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 9, 2020
• Study Start: June 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 15, 2019
• Last Updated: January 22, 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 availability

Locations

IT (1)