Prismatic Lenses and tDCS in Neglect

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Effect of Prismatic Lenses in Association With tDCS in Patients With Neglect: a Pilot Study

Conditions
-----------------
Stroke, Ischemic

Intervention / Treatment
-----------------
* Combination Product: Prismatic adaptation and electric stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years ischemic stroke hospitalization within 90 days of the event Exclusion Criteria: heamorrhagic stroke history of neurological disease history of psychiatric disease use of alchool and drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients will receive anodic tEs combined with prismatic lenses for two weeks | Combination Product: Prismatic adaptation and electric stimulation<br>* Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group<br>|
| Sham Comparator: Control<br>Patients will receive sham tEs combined with prismatic lenses for two weeks | Combination Product: Prismatic adaptation and electric stimulation<br>* Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, neglect, tDCS, prismatic lenses