Gait Disorders, Neurologic, Gait, Festinating, Parkinson, Parkinson Disease, Parkinsonism
Conditions
Keywords
repetitive Transcranial Magnetic stimulation, rTMS, wearing sensors, wearables, step variability, gait variability, gait speed, dual-task, dual-task walking, turning
Brief summary
Objective of the study: To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology Design: Twenty Parkinson's disease patients with no dementia 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 a battery of gait and movement tests using wearing sensors technology .
Detailed description
There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation Objective of the study: To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology Design: Parkinson's disease 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 a battery of gait and movement tests using wearing sensors technology. Sensors assessment: The following gait parameters will be evaluated in normal and cognitive/motor dual-tasks: i) step length ii) step variability iii) step phases iv) turning speed
Interventions
DEVICErepetitive transcranial magnetic stimulation
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Sponsors
University of Kiel
Università degli Studi di Brescia
Fondazione Europea di Ricerca Biomedica Ferb Onlus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
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)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* established Parkinson's disease * ability to stand alone and walk without support
Exclusion criteria
* dementia or behavioral alterations * contraindication to stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step variability in dual-task walking | Changes from Baseline to immediately after stimulation | Step variability will be assessed in normal, cognitive/motor dual-task conditions walking |
| Step length in dual-task walking | Changes from Baseline to immediately after stimulation | Step length will be assessed in normal, cognitive/motor dual-task conditions |
| Gait speed in dual-task walking | Changes from Baseline to immediately after stimulation | Gait speed will be assessed in normal, cognitive/motor dual-task conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Turning speed in timed up and go tests | Changes from Baseline to immediately after stimulation | Turning will be assessed y wearing sensors during timed up and go tests |
| total distance of dual-task walking | Changes from Baseline to immediately after stimulation | The total distance of one minute normal/motor/cognitive dual-task walking will be assessed |
Countries
Italy
Contacts
Primary ContactAndrea Pilotto, MD
Backup ContactCristina Rizzetti
Outcome results
None listed