An interventional study of repetitive transcranial magnetic stimulation in Parkinson, Parkinson Disease and Gait Disorders, Neurologic, sponsored by Fondazione Europea di Ricerca Biomedica Ferb Onlus. Status unknown at 1 site in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Fondazione Europea di Ricerca Biomedica Ferb Onlus · Not applicable, Interventional, and Treatment
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 .
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Fondazione Europea di Ricerca Biomedica Ferb Onlus is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
Step variability in dual-task walking
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Time frame: 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
Time frame: 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
Time frame: Changes from Baseline to immediately after stimulation
Turning speed in timed up and go tests
Turning will be assessed y wearing sensors during timed up and go tests
Time frame: 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
Time frame: Changes from Baseline to immediately after stimulation
Plan to share: Yes — The whole study will be published in medical journal
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Fondazione Europea di Ricerca Biomedica Ferb Onlus