Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-03-01
2017-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cerebellar iTBS
Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
Sham iTBS
Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
Interventions
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REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
Eligibility Criteria
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Inclusion Criteria
* Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS \<15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
* No contraindication to brain MRI
* MEP recordable in order to evaluate the resting motor threshold (RMT)
Exclusion Criteria
* Severe general impairment or concomitant diseases (tumors, etc.)
* Age\> 80 years
* Infections in progress
* Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
* Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.
30 Years
80 Years
ALL
No
Sponsors
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I.R.C.C.S. Fondazione Santa Lucia
OTHER
Responsible Party
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Giacomo Koch
Head of Laboratory
Locations
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Santa Lucia Foundation
Rome, , Italy
Countries
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References
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Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
Other Identifiers
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RF-2011-02349953
Identifier Type: -
Identifier Source: org_study_id
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