Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. METHODS: We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. RESULTS: In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. CONCLUSIONS: In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641.

Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

BACKGROUND: Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia. METHODS: The PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups - stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0-12) at 3 months. FINDINGS: Of 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11·4 (1·7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11·8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke (n = 79) -6·7 (-7·8, -5·5), ventilated stroke (n = 98) -6·5 (-7·6, -5·5); ventilation acquired (n = 35) -6·6 (-8·4, -4·8); traumatic brain injury (n = 24) -4·5 (-6·6, -2·4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them (p = 0·32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated (n = 66) -7·5 (-8·6, -6·5) versus not decannulated (n = 33) -2·1 (-3·2, -1·0) (p<0·001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9·2%) the most frequent SAE. INTERPRETATION: In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration. FUNDING: Phagenesis Ltd.

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study.

BACKGROUND: Recruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible patients at hospital sites that keep screening logs in the ongoing REstart or STop Antithrombotics Randomised Trial (RESTART), which seeks to determine whether to start antiplatelet drugs after ICH. METHOD: By the end of May 2015, 158 participants had been recruited at 108 active sites in RESTART. The trial coordinating centre invited all sites that kept screening logs to submit screening log data, followed by one reminder. We checked the integrity of data, focused on the completeness of data about potentially eligible patients and categorised the reasons they were not randomised. RESULTS: Of 108 active sites, 39 (36%) provided usable screening log data over a median of ten (interquartile range = 5-13) months of recruitment per site. During this time, sites screened 633 potentially eligible patients and randomised 53 (8%) of them. The main reasons why 580 patients were not randomised were: 43 (7%) patients started anticoagulation, 51 (9%) patients declined, 148 (26%) patients' stroke physicians were not uncertain about using antiplatelet drugs, 162 (28%) patients were too unwell and 176 (30%) patients were not randomised due to other reasons. CONCLUSION: RESTART recruited ~8% of eligible patients. If more physicians were uncertain about the therapeutic dilemma that RESTART is addressing, RESTART could have recruited up to four times as many participants. The trial coordinating centre continues to engage with physicians about their uncertainty. TRIAL REGISTRATION: EU Clinical Trials, EudraCT 2012-003190-26 . Registered on 3 July 2012.

Acquisition and short-term retention of inhaler techniques require intact executive function in elderly subjects.

BACKGROUND: patients with dementia are almost invariably unable to use any form of inhaler. Some elderly patients are unable to learn to use a metered dose inhaler or Turbohaler despite a normal abbreviated mental test score. Studies have shown that in many people this is due to unrecognised cognitive impairment and/or dyspraxia. The executive domains of cognition are particularly important in planning and sequencing; it might be expected therefore that disordered frontal (executive) function could be a predictor of poor inhaler technique in subjects with no overt features of dementia. OBJECTIVE: to explore the relationship between cognitive, and executive, function and the ability to acquire metered dose inhaler and Turbohaler technique in old age. DESIGN: a prospective randomised observational study with blinded evaluation. SUBJECTS: 30 inhaler-naive inpatients (21 female) with a mean age of 85 (range 75-94) and having a normal (8-10) abbreviated mental test score. METHODS: subjects received standardised metered dose inhaler and Turbohaler training and were scored on an analogue scale (for metered dose inhaler) or for competence (Turbohaler) the following day. The Mini-Mental State Examination and EXIT25 (for executive function) were performed by separate observers. RESULTS: significant correlation was found between the metered dose inhaler score and Mini-Mental State Examination (r 0.540, P<0.002) and EXIT25 (r -0.702, P<0.0001). Threshold effects emerged for the metered dose inhaler in that 18/19 with a competent score compared to 2/11 scored as incompetent had a Mini-Mental State Examination of >23 (P<0.01) and 19/19 compared to 0/11 had an EXIT25 of <15 (P<0.01). Similarly, for the Turbohaler 21/21 of the competent subjects had a Mini-Mental State Examination of >23 compared with 3/9 incompetent subjects (P<0.01), with 21/21 competent compared with 0/9 incompetent having an EXIT25 <15 (P<0.01). CONCLUSION: acquisition and short-term retention of metered dose inhaler and Turbohaler techniques is unlikely to be successful in frail elderly people who have an abnormal Mini-Mental State Examination and/or EXIT25 test. The latter test, when abnormal, is probably the superior predictor of inability to learn inhaler techniques.

Caffeine reduces cerebral blood flow in patients recovering from an ischaemic stroke.

BACKGROUND: Caffeine is present in a variety of beverages and food and is widely consumed. In a previous study of patients recovering from an acute ischaemic stroke using transcranial Doppler ultrasound we demonstrated a fall in middle cerebral artery blood velocity of 12% following ingestion of 250 mg caffeine. The aim of this study was to investigate if this velocity change reflected a change in cerebral blood flow. METHODS: The study used a randomised, double blind, cross-over design. Nineteen patients recovering from an acute ischaemic stroke in the middle cerebral artery territory and 10 controls attended two sessions, having abstained from caffeine for 48 hours previously. At each session cerebral blood flow was measured four times using xenon clearance, twice before the oral administration of 250 mg caffeine or matched placebo, and twice after. Similarly, three middle cerebral artery blood velocity readings using transcranial Doppler were made prior to administration and four after. RESULTS: The caffeine resulted in a significant fall in cerebral blood flow and middle cerebral artery blood velocity compared to placebo. CONCLUSIONS: Since caffeine is present in the diet of most patients recovering from an acute ischaemic stroke this effect may have adverse clinical consequences.