Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation

Study Overview
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Brief Summary
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Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term. Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term. Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.

Official Title
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Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation

Conditions
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Neurologic Neglect Syndrome

Intervention / Treatment
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* Device: transcranial direct current stimulation (tDCS)
* Device: Control: placebo stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Right-handed All subjects must be between the ages of 18-80 Patient with unilateral negligence consecutive to a right hemispheric stroke Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129 Stroke >1 month prior to study enrollment Exclusion Criteria: Degenerative neurological complaint Uncontrolled epilepsy Temporo-spatial disorientation Language disorders or psychiatric disorders preventing understanding instructions History of prior stroke, multiple stroke Medical condition not stabilized Pregnancy Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object) Intra-cranial material Unweaned alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A Anodal tDCS and prismatic adaptation<br>anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week). | Device: transcranial direct current stimulation (tDCS)<br>* Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).<br>|
| Placebo Comparator: Arm B: control<br>Prismatic adaptation with placebo stimulation | Device: Control: placebo stimulation<br>* electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural Inattention Test (BIT) | assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion. | Change in BIT score between the baseline sessions average and score measured at week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negligence Battery Test (BTN) | Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions | before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) | 
| Functional independence scale (MIF) | Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions | before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) | 
| Catherine Bergego scale (ECB) | Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions | baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) | 
| Jamar | Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions | baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation