Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Abdominal massage for the alleviation of symptoms of constipation in people with Parkinson's: a randomised controlled pilot study.

BACKGROUND: constipation is one of the most common non-motor features of Parkinson's affecting up to 90% of patients. In severe cases, it can lead to hospitalisation and is usually managed with laxatives which in themselves can lead to side effects. Abdominal massage has been used as adjunct in the management of constipation in various populations, but not in those with Parkinson's. OBJECTIVE: the primary objective was to test the recruitment, retention and the appropriateness of the intervention methods and outcome measures. METHODS: thirty-two patients with Parkinson's were recruited from three movement disorder clinics and were randomised to receive either 6 weeks of daily abdominal massage plus lifestyle advice on managing constipation (Intervention Group, n = 16) or lifestyle advice (Control Group, n = 16). Data were collected prior to group allocation (Baseline), at Week 6 (following intervention) and 4 weeks later (Week 10). Outcome tools included the Gastrointestinal Rating Scale and a bowel diary. RESULTS: constipation has a negative impact on quality of life. The study recruited to target, retention was high and adherence to the study processes was good. The massage was undertaken as recommended during the 6 weeks of intervention with 50% continuing with the massage at 10 weeks. Participants in both groups demonstrated an improvement in symptoms, although this was not significantly different between the groups. CONCLUSION: abdominal massage, as an adjunct to management of constipation, offers an acceptable and potentially beneficial intervention to patients with Parkinson's.

Evaluation of delirium screening tools in geriatric medical inpatients: a diagnostic test accuracy study.

INTRODUCTION: screening all unscheduled older adults for delirium is recommended in national guidelines, but there is no consensus on how to perform initial assessment. AIM: to evaluate the test accuracy of five brief cognitive assessment tools for delirium diagnosis in routine clinical practice. METHODS: a consecutive cohort of non-elective, elderly care (older than 65 years) hospital inpatients admitted to a geriatric medical assessment unit of an urban teaching hospital. Reference assessments were clinical diagnosis of delirium performed by elderly care physicians. Routine screening tests were: Abbreviated Mental Test (AMT-10, AMT-4), 4 A's Test (4AT), brief Confusion Assessment Method (bCAM), months of the year backwards (MOTYB) and informant Single Question in Delirium (SQiD). RESULTS: we assessed 500 patients, mean age 83 years (range = 66-101). Clinical diagnoses were: 93 of 500 (18.6%) definite delirium, 104 of 500 (20.8%) possible delirium and 277 of 500 (55.4%) no delirium; 266 of 500 (53.2%) were identified as definite or possible dementia. For diagnosis of definite delirium, AMT-4 (cut-point < 3/4) had a sensitivity of 92.7% (95% confidence interval (CI): 84.8-97.3), with a specificity of 53.7% (95% CI: 48.1-59.2); AMT-10 (<4/10), MOTYB (<4/12) and SQiD showed similar performance. bCAM had a sensitivity of 70.3% (95% CI: 58.5-80.3) with a specificity of 91.4% (95% CI: 87.7-94.3). 4AT (>4/12) had a sensitivity of 86.7% (95% CI: 77.5-93.2) and specificity of 69.5% (95% CI: 64.4-74.3). CONCLUSIONS: short screening tools such as AMT-4 or MOTYB have good sensitivity for definite delirium, but poor specificity; these tools may be reasonable as a first stage in assessment for delirium. The 4AT is feasible and appears to perform well with good sensitivity and reasonable specificity.

Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson's disease-STARTUP.

INTRODUCTION: Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. OBJECTIVES: Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. METHODS AND ANALYSIS: An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN12437878; Pre-results.

Sensory Electrical Stimulation Cueing May Reduce Freezing of Gait Episodes in Parkinson's Disease.

Introduction: Freezing of gait (FoG) is a movement abnormality that presents with advancing Parkinson's disease (PD) and is one of the most debilitating symptoms of the disease. The mainstay of nonpharmacological management of FoG is typically through external cueing techniques designed to relieve or prevent the freezing episode. Previous work shows that electrical stimulation may prove useful as a gait guidance technique, but further evidence is required. The main objective of this study was to determine whether a "fixed" rhythmic sensory electrical stimulation (sES) cueing strategy would significantly (i) reduce the time taken to complete a walking task and (ii) reduce the number of FoG episodes occurring when performing the task. Methods: 9 participants with idiopathic PD performed a self-identified walking task during both control (no cue) and cueing conditions. The self-identified walking task was a home-based daily walking activity, which was known to result in FoG for that person. A trained physiotherapist recorded the time taken to complete the walking task and the number of FoG episodes which occurred during the task. Data were analyzed by paired t-tests for both the time to complete a walking task and the number of FoG episodes occurring. Results: sES cueing resulted in a reduction in the time taken to complete a walking task and in the number of FoG episodes occurring during performance of this task by 14.23 ± 11.15% (p=0.009) and 58.28 ± 33.89% (p=0.002), respectively. Conclusions: This study shows a positive effect of "fixed" rhythmic sES on the time taken to complete a walking task and on the number of FoG episodes occurring during the task. Our results provide evidence that sES cueing delivered in a "fixed" rhythmic manner has the potential to be an effective cueing mechanism for FoG prevention.

Outcomes of screening Parkinson's patients for QTc prolongation.

BACKGROUND: Parkinson's disease (PD) patients are commonly prescribed medication that has recently been associated with QTc prolongation on electrocardiograms (ECG). In addition, research suggests that PD patients may be more at risk of QTc prolongation. OBJECTIVE: To evaluate the outcomes of screening PD patients for QTc prolongation. METHODS: ECG analysis of PD patients attending for routine outpatient PD review in 2012 who were prescribed medication that could potentially prolong their QTc interval. We noted prescribing changes and any repeat ECG findings. We also reviewed any recent ECGs of clinic patients not on QTc prolonging medication. RESULTS: A third of our PD clinic patients (63/192) were prescribed QTc prolonging medication. Of these 61/63 (97%) ECGs were available. 20/61 (33%) showed QTc prolongation. 6/20 (30%) had significant prolongation >500 ms. 18/20 (90%) patients had medication changes made, and of the 12/18 (67%) ECGs repeated in this group all improved with 11 demonstrating normalisation of the QTc interval. Of the 51 available ECGs in patients not prescribed QTc prolonging medication 3/51 (6%) showed QTc prolongation. Statistical analysis showed that QTc prolongation was significantly associated with the prescription of QTC prolonging medication and stage of PD. CONCLUSION: QTc prolongation in PD patients caused by medication is a major modifiable risk factor. A routine ECG should be considered if a PD patient is currently prescribed medication that can prolong the QTc interval. Also consideration should be given to performing this simple test prior to commencing QTc prolonging medication.