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Challenges in Recruitment for the Study of Noninvasive Brain Stimulation in Stroke: Lessons from Deep Brain Stimulation.

ABSTRACT: Noninvasive brain stimulation (NIBS) can augment functional recovery following stroke; however, the technique lacks regulatory approval. Low enrollment in NIBS clinical trials is a key roadblock. Here, we pursued evidence to support the prevailing opinion that enrollment in trials of NIBS is even lower than enrollment in trials of invasive, deep brain stimulation (DBS).We compared 2 clinical trials in stroke conducted within a single urban hospital system, one employing NIBS and the other using DBS, (1) to identify specific criteria that generate low enrollment rates for NIBS and (2) to devise strategies to increase recruitment with guidance from DBS.Notably, we found that enrollment in the NIBS case study was 5 times lower (2.8%) than the DBS trial (14.5%) (?(2)?=?20.815, P?

SUBMITTER: Potter-Baker KA

PROVIDER: S-EPMC4799781 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Challenges in Recruitment for the Study of Noninvasive Brain Stimulation in Stroke: Lessons from Deep Brain Stimulation.

Potter-Baker Kelsey A KA Bonnett Corin E CE Chabra Patrick P Roelle Sarah S Varnerin Nicole N Cunningham David A DA Sankarasubramanian Vishwanath V Pundik Svetlana S Conforto Adriana B AB Machado Andre G AG Plow Ela B EB

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association 20160202 4

<h4>Objective</h4>Noninvasive brain stimulation (NIBS) can augment functional recovery following stroke; however, the technique lacks regulatory approval. Low enrollment in NIBS clinical trials is a key roadblock. Here, we pursued evidence to support the prevailing opinion that enrollment in trials of NIBS is even lower than enrollment in trials of invasive, deep brain stimulation (DBS).<h4>Methods</h4>We compared 2 clinical trials in stroke conducted within a single urban hospital system, one e ...[more]

PMID: 26851211

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Project description:BackgroundDysphagia is a common sequelae after stroke. Noninvasive brain stimulation (NIBS) is a tool that has been used in the rehabilitation process to modify cortical excitability and improve dysphagia.ObjectiveTo systematically evaluate the effect of NIBS on dysphagia after stroke and compare the effects of two different NIBS.MethodsRandomized controlled trials about the effect of NIBS on dysphagia after stroke were retrieved from databases of PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP, and CBM, from inception to June 2021. The quality of the trials was assessed, and the data were extracted according to the Cochrane Handbook for Systematic Reviews of Interventions. A statistical analysis was carried out using RevMan 5.3 and ADDIS 1.16.8. The effect size was evaluated by using the standardized mean difference (SMD) and a 95% confidence interval (CI).ResultsUltimately, 18 studies involving 738 patients were included. Meta-analysis showed that NIBS could improve the dysphagia outcome and severity scale (DOSS) score (standard mean difference (SMD) = 1.44, 95% CI 0.80 to 2.08, P < 0.05) and the water swallow test score (SMD = 6.23, 95% CI 5.44 to 7.03, P < 0.05). NIBS could reduce the standardized swallowing assessment (SSA) score (SMD = -1.04, 95% CI -1.50 to -0.58, P < 0.05), the penetration-aspiration scale (PAS) score (SMD = -0.85, 95% CI -1.33 to -0.36, P < 0.05), and the functional dysphagia scale score (SMD = -1.05, 95% CI -1.48 to -0.62, P < 0.05). Network meta-analysis showed that the best probabilistic ranking of the effects of two different NIBS on the DOSS score is rTMS (P = 0.52) > tDCS (P = 0.48), the best probabilistic ranking of the SSA score is rTMS (P = 0.72) > tDCS (P = 0.28), and the best probabilistic ranking of the PAS score is rTMS (P = 0.68) > tDCS (P = 0.32).ConclusionExisting evidence showed that NIBS could improve swallowing dysfunction and reduce the occurrence of aspiration after stroke, and that rTMS is better than tDCS. Limited by the number of included studies, more large-sample, multicenter, double-blind, high-quality clinical randomized controlled trials are still needed in the future to further confirm the results of this research.

Dataset Information

Challenges in Recruitment for the Study of Noninvasive Brain Stimulation in Stroke: Lessons from Deep Brain Stimulation.

Publications

Challenges in Recruitment for the Study of Noninvasive Brain Stimulation in Stroke: Lessons from Deep Brain Stimulation.

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