Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy
- Conditions
- ParkinsonismProgressive Supranuclear PalsyFallGait, Rigid
- Interventions
- Device: repetitive transcranial magnetic stimulation
- Registration Number
- NCT04222218
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- probable PSP diagnosis
- ability to stand alone without support for at least 5 seconds
- ability to walk without aid for at least three meters
- dementia or behavioral alterations
- contraindications of stimulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Real Stimulation repetitive transcranial magnetic stimulation 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. Sham Stimulation repetitive transcranial magnetic stimulation 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)
- Primary Outcome Measures
Name Time Method Short Physical Performance Battery, total time (SPPB) Changes from Baseline to immediately after stimulation 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)
Static Balance tests, total time Changes from Baseline to immediately after stimulation 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.Tinetti Balance test (TBT) Changes from Baseline to immediately after stimulation Assessment of postural instability (0-28, higher scores indicate better performances)
Static Balance- area of sway Changes from Baseline to immediately after stimulation The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
Timed up and Go tests, total time (TUG) Changes from Baseline to immediately after stimulation 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
- Secondary Outcome Measures
Name Time Method PSP rating scale (PSP-RS) Changes from Baseline to immediately after stimulation Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Static Balance: wearable sensor analyses - velocity Changes from Baseline to immediately after stimulation the velocity of sway will be assessed during the postural instability tasks (unit of measure (mm/s)
Static Balance: wearable sensor analyses - jerk Changes from Baseline to immediately after stimulation The time-derived of acceleration of sway will be assessed during the postural instability tasks (unit of measure mm3/s)
Static Balance: wearable sensor analyses - acceleration Changes from Baseline to immediately after stimulation the acceleration of sway will be assessed during the postural instability tasks (unit of measure mm2/s)
Trial Locations
- Locations (1)
Parkinson's disease Rehabilitation Centre - FERB ONLUS
🇮🇹Trescore Balneario, Italy