Azienda Unità Sanitaria Locale, UOC di Medicina Riabilitativa e Neuroriabilitazione, Bologna, Italy.
IRCCS Istituto delle Scienze Neurologiche di Bologna, UO di Medicina Riabilitativa e Neuroriabilitazione, Casa dei Risvegli Luca de Nigris, Via Giulio Gaist, 6, 40139, Bologna, Italy.
Trials. 2021 Jan 6;22(1):24. doi: 10.1186/s13063-020-04943-6.
Left hemispatial neglect (LHN) is a neuropsychological syndrome often associated with right hemispheric stroke. Patients with LHN have difficulties in attending, responding, and consciously representing the right side of space. Various rehabilitation protocols have been proposed to reduce clinical symptoms related to LHN, using cognitive treatments, or on non-invasive brain stimulation. However, evidence of their benefit is still lacking; in particular, only a few studies focused on the efficacy of combining different approaches in the same patient.
In the present study, we present the SMART ATLAS trial (Stimolazione MAgnetica Ripetitiva Transcranica nell'ATtenzione LAteralizzata dopo Stroke), a multicenter, randomized, controlled trial with pre-test (baseline), post-test, and 12 weeks follow-up assessments based on a novel rehabilitation protocol based on the combination of brain stimulation and standard cognitive treatment. In particular, we will compare the efficacy of inhibitory repetitive-transcranial magnetic stimulation (r-TMS), applied over the left intact parietal cortex of LHN patients, followed by visual scanning treatment, in comparison with a placebo stimulation (SHAM control) followed by the same visual scanning treatment, on visuospatial symptoms and neurophysiological parameters of LHN in a population of stroke patients.
Our trial results may provide scientific evidence of a new, relatively low-cost rehabilitation protocol for the treatment of LHN.
ClinicalTrials.gov NCT04080999 . Registered on September 2019.
左侧空间忽略症(LHN)是一种常见于右脑卒中的神经心理学综合征。LHN 患者在注意、反应和有意识地表现右侧空间方面存在困难。已经提出了各种康复方案来减轻与 LHN 相关的临床症状,包括认知治疗或非侵入性脑刺激。然而,它们的益处仍缺乏证据;特别是,只有少数研究关注了在同一患者中结合不同方法的疗效。
在本研究中,我们介绍了 SMART ATLAS 试验(Stimolazione MAgnetica Ripetitiva Transcranica nell'ATtenzione LAteralizzata dopo Stroke),这是一项多中心、随机、对照试验,具有预测试(基线)、后测试和 12 周随访评估,基于一种新的康复方案,该方案结合了脑刺激和标准认知治疗。具体而言,我们将比较抑制性重复经颅磁刺激(r-TMS)在 LHN 患者左侧完整顶叶皮层上的应用,随后进行视觉扫描治疗,与安慰剂刺激(SHAM 对照)随后进行相同的视觉扫描治疗,在卒中患者群体中比较 LHN 的视觉空间症状和神经生理参数。
我们的试验结果可能为 LHN 治疗的一种新的、相对低成本的康复方案提供科学证据。
ClinicalTrials.gov NCT04080999。于 2019 年 9 月注册。