Clinical trial NCT04222218: Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy
Official title: Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy: a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Fall
Gait, Rigid
Parkinsonism
Keywords: repetitive Transcranial Magnetic stimulation
cerebellum
wearing sensors
static balance
Lead sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus
Sponsor class: OTHER
Collaborators: name: University of Brescia, Neurology Department
name: University of Kiel, Neurogeriatric Department
First posted: 2020-01-09
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: CROSSOVER
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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 theta Burst repetitive Transcranial magnetic stimulation

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:

Probable PSP patients able to walk and without dementia/behavioral disturbances 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.

Repetitive cerebellar theta burst stimulation will be performed by Duo-Mag XT100, 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.

A sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation)

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.

Sensors assessment:

The following parameters will be evaluated before and after stimulation (real vs sham): The parameter 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.

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: Short Physical Performance Battery, total time (SPPB)
timeFrame: Changes from Baseline to immediately after stimulation
measure: Timed up and Go tests, total time (TUG)
timeFrame: Changes from Baseline to immediately after stimulation
measure: Static Balance tests, total time
timeFrame: Changes from Baseline to immediately after stimulation
measure: Tinetti Balance test (TBT)
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: PSP rating scale (PSP-RS)
timeFrame: Changes from Baseline to immediately after stimulation
measure: Static Balance: wearable sensor analyses - velocity
timeFrame: Changes from Baseline to immediately after stimulation
measure: Static Balance: wearable sensor analyses - acceleration
timeFrame: Changes from Baseline to immediately after stimulation
measure: Static Balance: wearable sensor analyses - jerk
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: Università degli Studi di Brescia
name: Andrea Pilotto, MD
role: PRINCIPAL_INVESTIGATOR
References: