Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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

Official Title
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Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease:a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology

Conditions
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Parkinson, Parkinson Disease, Gait Disorders, Neurologic, Parkinsonism, Gait, Festinating

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: established Parkinson's disease ability to stand alone and walk without support Exclusion Criteria: dementia or behavioral alterations contraindication to stimulation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real Stimulation<br>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<br>* Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description<br>|
| Placebo Comparator: Sham Stimulation<br>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<br>* Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step variability in dual-task walking | Step variability will be assessed in normal, cognitive/motor dual-task conditions walking | Changes from Baseline to immediately after stimulation | 
| Step length in dual-task walking | Step length will be assessed in normal, cognitive/motor dual-task conditions | Changes from Baseline to immediately after stimulation | 
| Gait speed in dual-task walking | Gait speed will be assessed in normal, cognitive/motor dual-task conditions | Changes from Baseline to immediately after stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turning speed in timed up and go tests | Turning will be assessed y wearing sensors during timed up and go tests | Changes from Baseline to immediately after stimulation | 
| total distance of dual-task walking | The total distance of one minute normal/motor/cognitive dual-task walking will be assessed | Changes from Baseline to immediately after stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive Transcranial Magnetic stimulation, rTMS, wearing sensors, wearables, step variability, gait variability, gait speed, dual-task, dual-task walking, turning