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The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebellar iTBS | Active Comparator | Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. |
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| Sham iTBS | Sham Comparator | Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale (BBS) for gait and balance | Assessment of gait and balance functions | Change from baseline at the end of three weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) scale | Assessment of motor functions | Change from baseline at the end of three weeks treatment |
| Barthel Index (BI) | Assessment of functional abilities |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Lucia Foundation | Rome | 00179 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30476999 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Change from baseline at the end of three weeks treatment |
| Neurophysiological assessment of cortical activity | evaluation of cortical activity by means of TMS in combination with EEG | Change from baseline at the end of three weeks treatment |
| Gait analysis | evaluation of locomotion | Change from baseline at the end of three weeks treatment |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |