Neurologic Neglect Syndrome
Conditions
Keywords
Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation
Brief summary
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.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
DEVICEControl: placebo stimulation
electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioural Inattention Test (BIT) | Change in BIT score between the baseline sessions average and score measured at week 11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negligence Battery Test (BTN) | 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) | Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions |
| Functional independence scale (MIF) | 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) | Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions |
| Catherine Bergego scale (ECB) | 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) | Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions |
| Jamar | 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) | Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions |
Countries
France
Outcome results
None listed