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| Name | Class |
|---|---|
| Azienda USL Toscana Sud Est | OTHER_GOV |
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The goal of this study is to to evaluate the effect and feasibility of a rehabilitation protocol with prismatic lenses associated with tDCS, compared to a prismatic lens rehabilitation protocol associated with sham stimulation, in reducing the signs of neglect in a group of patients with spatial heminegligence following ischemic stroke of the right hemisphere.
The secondary objective is to evaluate the impact of this rehabilitation protocol on functional outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients will receive anodic tEs combined with prismatic lenses for two weeks |
|
| Control | Sham Comparator | Patients will receive sham tEs combined with prismatic lenses for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prismatic adaptation and electric stimulation | Combination Product | Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological outcome | Oxford Cognitive Screening (OCS): is structured in 10 subtests: picture naming (0-4); semantics (0-3); orientation (0-4); visual field (0-4); sentence reading (0-15); number writing (0-3); calculation (0-4); broken hearts (0-50); praxis (0-12); recall and recognition (0-4); trails task (0-13) | Change from baseline OCS at 2 weeks |
| Neuropsychological outcome | The semi structured scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome | Change form baseline the semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks |
| Neuropsychological outcome | The semi structured scale for the functional evaluation of personal neglect (0-9); high score means worse outcome | Change form baseline the semi structured scale for the functional evaluation of personal neglect at 2 weeks |
| Neuropsychological outcome | Bergegò Scale (0-30); high score means a better outcome | Change from baseline the Bergegò Scale at 2 weeks. |
| Functional outcome | Barthel Index (0-100); high score means a better outcome | Change from baseline the Barthel Index at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simona Spaccavento | Contact | +393332783524 | simona.spaccavento@icsmaugeri.it |
| Name | Affiliation | Role |
|---|---|---|
| Simona Spaccavento | Istituti Clinici Scientifici Maugeri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituti Clinici Scientifici Maugeri | Recruiting | Bari | Ba | 70025 | Italy |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |