NCT04238000

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fondazione Europea di Ricerca Biomedica Ferb Onlus · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	repetitive transcranial magnetic stimulation	Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: Italy