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Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect
Neuropsychological Rehabilitation ( IF 2.7 ) Pub Date : 2020-06-05 , DOI: 10.1080/09602011.2020.1767161
Gemma Learmonth 1, 2 , Christopher S Y Benwell 2, 3 , Gesine Märker 2 , Diana Dascalu 2 , Matthew Checketts 2, 4 , Celestine Santosh 5 , Mark Barber 6 , Matthew Walters 7 , Keith W Muir 1 , Monika Harvey 2
Affiliation  

ABSTRACT

Up to 80% of people who experience a right-hemisphere stroke suffer from hemispatial neglect. This syndrome is debilitating and impedes rehabilitation. We carried out a clinical feasibility trial of transcranial direct current stimulation (tDCS) and a behavioural rehabilitation programme, alone or in combination, in patients with neglect. Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task. Primary outcomes were recruitment and retention rates, with secondary outcomes effect sizes on measures of neglect and quality of life, assessed directly after the interventions, and at 6 months follow up. Of 288 confirmed stroke cases referred (representing 7% of confirmed strokes), we randomized 8% (0.6% of stroke cases overall). The largest number of exclusions (91/288 (34%)) were due to medical comorbidities that prevented patients from undergoing 10 intervention sessions. We recruited 24 patients over 29 months, with 87% completing immediate post-intervention and 67% 6 month evaluations. We established poor feasibility of a clinical trial requiring repeated hospital-based tDCS within a UK hospital healthcare setting, either with or without behavioural training, over a sustained time period. Future trials should consider intensity, duration and location of tDCS neglect interventions.

Trial registration: ClinicalTrials.gov identifier: NCT02401724.



中文翻译:

中风患者的非侵入性脑刺激 (NIBS):一项前瞻性随机开放盲法终点 (PROBE) 可行性试验,使用经颅直流电刺激 (tDCS) 治疗中风后半空间忽视

摘要

多达 80% 的右脑卒中患者患有半脑空间忽视。这种综合症使人衰弱并阻碍康复。我们对忽视患者单独或联合进行了经颅直流电刺激 (tDCS) 和行为康复计划的临床可行性试验。右脑卒中后 > 4 周的患者被随机分配到 10 次 tDCS、10 次行为干预、联合干预或控制任务。主要结果是招募和保留率,次要结果对忽视和生活质量的影响大小,在干预后直接评估,并在 6 个月的随访时进行评估。在转诊的 288 例确诊卒中病例中(占确诊卒中病例的 7%),我们随机分配了 8%(占卒中病例总数的 0.6%)。最大数量的排除 (91/288 (34%)) 是由于医学合并症导致患者无法接受 10 次干预。我们在 29 个月内招募了 24 名患者,其中 87% 完成了立即干预后评估,67% 完成了 6 个月评估。我们确定了一项临床试验的可行性较差,该试验需要在英国医院医疗保健环境中在持续的时间段内进行重复的基于医院的 tDCS,无论是否进行行为培训。未来的试验应考虑 tDCS 忽视干预的强度、持续时间和位置。我们确定了一项临床试验的可行性较差,该试验需要在英国医院医疗保健环境中在持续的时间段内进行重复的基于医院的 tDCS,无论是否进行行为培训。未来的试验应考虑 tDCS 忽视干预的强度、持续时间和位置。我们确定了一项临床试验的可行性较差,该试验需要在英国医院医疗保健环境中在持续的时间段内进行重复的基于医院的 tDCS,无论是否进行行为培训。未来的试验应考虑 tDCS 忽视干预的强度、持续时间和位置。

试用注册: ClinicalTrials.gov 标识符:NCT02401724.

更新日期:2020-06-05
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