Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial

Abstract

BackgroundUnilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), has been used in people who have been affected by USN after stroke. The effects of such treatment could provide new insights for health professionals and policy-makers. The aim of this study will be to evaluate the effectiveness and safety of tDCS for USN after stroke.MethodsA prospective randomized controlled trial with two parallel groups will be conducted, which will aim to recruit 60 patients with USN after ischemic or hemorrhagic stroke. Participants will be randomly placed into the following four treatment groups: (1) anodal tDCS over the right parietal lobe (n = 15), (2) cathodal tDCS over the left parietal lobe (n = 15), (3) a sham group of anodal tDCS over the right parietal lobe (n = 15), and (4) a sham group of cathodal tDCS over the left parietal lobe (n = 15). Blinded assessors will conduct two baseline assessments and one post-intervention assessment. The primary outcome measure will be the level of USN as assessed by the conventional Behavioral Inattention Tasks and the Catherine Bergego Scale. Secondary measures will include neurological capacity (based on the Scandinavian Stroke Scale), functional capacity (based on the Functional Independence Measure and Modified Rankin Scale), autonomy (based on the Barthel Index), and quality of life (based on the EuroQol-5D). Group allocation will be concealed, and all analyses will be based on an intention-to-treat principle.DiscussionThis study will explore the effects of more than 15 sessions of tDCS on the level of USN, functional capacity, autonomy, and quality of life in patients with USN after stroke. This proposed study has the potential to identify a new, evidence-based intervention that can enhance perception and independent living in patients with USN after stroke.Trial registrationREBEC - RBR-78jvzx, registered on 13 March 2016.

Non‐invasive Brain Stimulation Can Reduce Unilateral Spatial Neglect after Stroke: ELETRON Trial

“…Information on the inclusion and exclusion criteria, interventions, and assessments has been published previously. 16…”

Non-Invasive Brain Stimulation (TMS/tDCS) and Rehabilitation for Stroke and Parkinson’s

“…It has mostly been used to treat impairment of upper extremity motor function [22], unilateral spatial neglect (USN) [23], pain [24] and depression [25]. When used to treat hemiplegic arms, a constant direct current of 1-2 mA is given for 10-40 min using a pair of sponge electrodes (5 cm × 7 cm) placed on the scalp overlying the motor cortex and the contralateral supraorbital region.…”

“…NIBS, using either rTMS or tDCS, may be combined with physical therapy [23], occupational therapy Kakuda et al [16], BWSTT training, robotic therapy [32], constraint-induced (CI) therapy [3] and simultaneous percutaneous neuromuscular stimulation. Lee et al [29] investigated the effects of cathodal tDCS combined with visual reality (VR) therapy for upper extremity training in patients with subacute stroke.…”

“…In a study by Middleton et al, 5 participants with chronic stroke completed 24 sessions of upper extremity physical therapy combined with tDCS over the motor cortex [23], and improvements on the UE Fugl-Meyer assessment (FMA), BBT and robotic measures were largely sustained at 6 months. Kakuda et al [16] However, more studies are needed to clarify the clinical changes underlying the reduction in spasticity induced by NIBS [20].…”

Homonymous hemianopsia versus unilateral spatial neglect rehabilitation strategies in stroke patients

“…Understanding the function of the visual system in and neuroplasticity phenomena can be an important step toward a better rehabilitation of these patients, improving their outcome chances, and finally their life quality. Unilateral spatial neglect (USN) consist in unresponsiveness to any visual or tactile stimulus on one side of the body (contralateral side defect), that cannot be attributed to sensory or motor deficit (20). This condition is associated with lesions in the right hemisphere, particularly in the right hemisphere (inferior parietal lobe, superior temporal gyrus and/or inferior frontal gyrus) and with poor prognosis (21).…”