| 1. |
- Alt Murphy, Margit, 1970, et al.
(författare)
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An upper body garment with integrated sensors for people with neurological disorders – early development and evaluation
- 2019
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Ingår i: BMC Biomedical Engineering. - : Springer Science and Business Media LLC. - 2524-4426. ; 1:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: To develop a novel wearable garment with integrated sensors for continuous monitoring of physiological and movement related variables to evaluate progression, tailor treatments and improve diagnosis in epilepsy, Parkinson’s disease and stroke. Methods: An iterative development process and evaluation of an upper body garment with integrated sensors included: identification of user needs, specification of technical and garment requirements, garment development and production as well as evaluation of garment design, functionality and usability. The project is a multidisciplinary collaboration with experts from medical, engineering, textile, and material science within the wearITmed consortium. The work was organized in regular meetings, task groups and hands-on workshops. User needs were identified using results from a mixed-methods systematic review, a focus group study and expert groups. Usability was evaluated in 19 individuals (13 controls, 6 patients with Parkinson’s disease) using semi-structured interviews and qualitative content analysis. Results: A prototype designed to monitor movements and heart rate was developed. The garment was well accepted by the users regarding design and comfort, although the users were cautious about the technology and suggested improvements. All electronic components passed a washability test. The most robust data was obtained from accelerometer and gyroscope sensors while the electrodes for heart rate registration were sensitive to motion. artefacts. The algorithm development within the wearITmed consortium has shown promising results. Conclusions: The prototype was accepted by the users. Technical improvements are needed, but preliminary data indicate that the garment has potential to be used as a tool for diagnosis and treatment selection and could provide added value for monitoring seizures in epilepsy, fluctuations in PD and activity levels in stroke. Future work aims to improve the prototype further, develop algorithms, and evaluate the functionality and usability in targeted patient groups. The potential of incorporating blood pressure and heart-rate variability monitoring will also be explored.
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| 2. |
- Senek, Marina, et al.
(författare)
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Levodopa/carbidopa microtablets in Parkinson's disease : a study of pharmacokinetics and blinded motor assessment
- 2017
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Ingår i: European Journal of Clinical Pharmacology. - Heidelberg, Germany : Springer. - 0031-6970 .- 1432-1041 .- 0014-2999. ; 73:5, s. 563-571
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Tidskriftsartikel (refereegranskat)abstract
- Background: Motor function assessments with rating scales in relation to the pharmacokinetics of levodopa may increase the understanding of how to individualize and fine-tune treatments.Objectives: This study aimed to investigate the pharmacokinetic profiles of levodopa-carbidopa and the motor function following a single-dose microtablet administration in Parkinson’s disease.Methods: This was a single-center, open-label, single-dose study in 19 patients experiencing motor fluctuations. Patients received 150% of their individual levodopa equivalent morning dose in levodopa-carbidopa microtablets. Blood samples were collected at pre-specified time points. Patients were video recorded and motor function was assessed with six UPDRS part III motor items, dyskinesia score, and the treatment response scale (TRS), rated by three blinded movement disorder specialists.Results: AUC0–4/dose and Cmax/dose for levodopa was found to be higher in Parkinson’s disease patients compared with healthy subjects from a previous study, (p = 0.0008 and p = 0.026, respectively). The mean time to maximum improvement in sum of six UPDRS items score was 78 min (±59) (n = 16), and the mean time to TRS score maximum effect was 54 min (±51) (n = 15). Mean time to onset of dyskinesia was 41 min (±38) (n = 13).Conclusions: In the PD population, following levodopa/carbidopa microtablet administration in fasting state, the Cmax and AUC0–4/dose were found to be higher compared with results from a previous study in young, healthy subjects. A large between subject variability in response and duration of effect was observed, highlighting the importance of a continuous and individual assessment of motor function in order to optimize treatment effect.
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| 3. |
- Ulfsdotter Gunnarsson, Katarina, et al.
(författare)
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Randomized study of two different consent procedures on recall : a study within a digital alcohol intervention trial
- 2024
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Ingår i: Trials. - : BioMed Central Ltd. - 1745-6215. ; 25:1
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Individuals’ comprehension of the information provided in consent forms should fundamentally influence whether to participate initially in a study and later whether to remain a participant. Existing evidence, however, suggests that participants do not thoroughly read, comprehend, or recall the information in consent forms. This study aimed to better understand how well participants recalled trial procedure information in the consent materials they received prior to taking part in a trial of a digital alcohol intervention. Method: This study was nested within an online effectiveness trial. The study included a contrast between two layout approaches to present the trial procedure information: one where all materials were shown on the same page (One page) and one where participants had to click on links to get materials for certain parts of the study information (Active request). Recall of trial procedures was measured 2 months post-randomization with four questions. Participants were also asked to leave a comment after each question. Result: Of the 2437 individuals who registered interest in the parent trial, 1197 were randomized to One page and 1240 were randomized to Active request. Approximately 90% consented to participate and 53% of the participants responded to the recall questionnaire. Contrasting the consent layout showed no marked differences between groups in three out of the four questions on recall of trial procedures. There was, however, evidence that recall of aspects of how personal data would be handled during the trial did differ between the two groups, with the Active request group reporting less recall than the One page group. Free-text comments were used to give nuance to the quantitative analysis. Conclusion: Participants exposed to different layouts of trial procedure information exhibited varying levels of information recall 2 months after consenting. The findings highlight the influence of the presentation of consent forms, which should be given attention when designing trials. Trial registration: ISRCTN ISRCTN48317451. Registered 6 December 2018, https://www.isrctn.com/ISRCTN48317451.
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| 4. |
- Andersson, Sofi A., 1970, et al.
(författare)
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Arm impairment and walking speed explain real-life activity of the affected Arm and leg after stroke
- 2021
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Ingår i: Journal of Rehabilitation Medicine. - : Foundation for Rehabilitation Information. - 1650-1977 .- 1651-2081. ; 53:6
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To determine to what extent accelerometer-based arm, leg and trunk activity is associated with sensorimotor impairments, walking capacity and other factors in subacute stroke. Design: Cross-sectional study. Patients: Twenty-six individuals with stroke (mean age 55.4 years, severe to mild motor impairment). Methods: Data on daytime activity were collected over a period of 4 days from accelerometers placed on the wrists, ankles and trunk. A forward stepwise linear regression was used to determine associations between free-living activity, clinical and demographic variables. Results: Arm motor impairment (Fugl-Meyer Assessment) and walking speed explained more than 60% of the variance in daytime activity of the more-affected arm, while walking speed alone explained 60% of the more-affected leg activity. Activity of the less-affected arm and leg was associated with arm motor impairment (R2=0.40) and independence in walking (R2=0.59). Arm activity ratio was associated with arm impairment (R2=0.63) and leg activity ratio with leg impairment (R2=0.38) and walking speed (R2=0.27). Walking-related variables explained approximately 30% of the variance in trunk activity. Conclusion: Accelerometer-based free-living activity is dependent on motor impairment and walking capacity. The most relevant activity data were obtained from more-affected limbs. Motor impairment and walking speed can provide some information about real-life daytime activity levels.
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| 5. |
- Hernández-Jiménez, Macaarena, et al.
(författare)
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APRIL : A double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke
- 2023
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Ingår i: Frontiers in Neurology. - : Frontiers Media S.A.. - 1664-2295. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- In the reperfusion era, a new paradigm of treating patients with endovascular treatment (EVT) and neuroprotective drugs is emerging as a promising therapeutic option for patients with acute ischemic stroke (AIS). In this context, ApTOLL, a Toll-like receptor 4 (TLR4) antagonist with proven neuroprotective effect in preclinical models of stroke and a very good pharmacokinetic and safety profile in healthy volunteers, is a promising first-in-class aptamer with the potential to address this huge unmet need. This protocol establishes the clinical trial procedures to conduct a Phase Ib/IIa clinical study (APRIL) to assess ApTOLL tolerability, safety, pharmacokinetics, and biological effect in patients with AIS who are eligible for EVT. This will be a multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to evaluate the administration of ApTOLL together with EVT in patients with AIS. The study population will be composed of men and non-pregnant women with confirmed AIS with a <6h window from symptoms onset to ApTOLL/placebo administration. The trial is currently being conducted and is divided into two parts: Phase Ib and Phase IIa. In Phase Ib, 32 patients will be allocated to four dose ascending levels to select, based on safety criteria, the best two doses to be administered in the following Phase IIa in which 119 patients will be randomized to three arms of treatment (dose A, dose B, and placebo).
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| 6. |
- Hernández-Jiménez, Macarena, et al.
(författare)
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Safety and Efficacy of ApTOLL in Patients With Ischemic Stroke Undergoing Endovascular Treatment
- 2023
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Ingår i: JAMA Neurology. - : JAMA. - 2168-6149 .- 2168-6157. ; 80:8, s. 779-788
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Tidskriftsartikel (refereegranskat)abstract
- Importance ApTOLL is a TLR4 antagonist with proven preclinical neuroprotective effect and a safe profile in healthy volunteers. Objective To assess the safety and efficacy of ApTOLL in combination with endovascular treatment (EVT) for patients with ischemic stroke. Design, Setting, and Participants This phase 1b/2a, double-blind, randomized, placebo-controlled study was conducted at 15 sites in Spain and France from 2020 to 2022. Participants included patients aged 18 to 90 years who had ischemic stroke due to large vessel occlusion and were seen within 6 hours after stroke onset; other criteria were an Alberta Stroke Program Early CT Score of 6 to 10, estimated infarct core volume on baseline computed tomography perfusion of 5 to 70 mL, and the intention to undergo EVT. During the study period, 4174 patients underwent EVT. Interventions In phase 1b, 0.025, 0.05, 0.1, or 0.2 mg/kg of ApTOLL or placebo; in phase 2a, 0.05 or 0.2 mg/kg of ApTOLL or placebo; and in both phases, treatment with EVT and intravenous thrombolysis if indicated. Main Outcomes and Measures The primary end point was the safety of ApTOLL based on death, symptomatic intracranial hemorrhage (sICH), malignant stroke, and recurrent stroke. Secondary efficacy end points included final infarct volume (via MRI at 72 hours), NIHSS score at 72 hours, and disability at 90 days (modified Rankin Scale [mRS] score). Results In phase Ib, 32 patients were allocated evenly to the 4 dose groups. After phase 1b was completed with no safety concerns, 2 doses were selected for phase 2a; these 119 patients were randomized to receive ApTOLL, 0.05 mg/kg (n = 36); ApTOLL, 0.2 mg/kg (n = 36), or placebo (n = 47) in a 1:1:√2 ratio. The pooled population of 139 patients had a mean (SD) age of 70 (12) years, 81 patients (58%) were male, and 58 (42%) were female. The primary end point occurred in 16 of 55 patients (29%) receiving placebo (10 deaths [18.2%], 4 sICH [7.3%], 4 malignant strokes [7.3%], and 2 recurrent strokes [3.6%]); in 15 of 42 patients (36%) receiving ApTOLL, 0.05 mg/kg (11 deaths [26.2%], 3 sICH [7.2%], 2 malignant strokes [4.8%], and 2 recurrent strokes [4.8%]); and in 6 of 42 patients (14%) receiving ApTOLL, 0.2 mg/kg (2 deaths [4.8%], 2 sICH [4.8%], and 3 recurrent strokes [7.1%]). ApTOLL, 0.2 mg/kg, was associated with lower NIHSS score at 72 hours (mean difference log-transformed vs placebo, −45%; 95% CI, −67% to −10%), smaller final infarct volume (mean difference log-transformed vs placebo, −42%; 95% CI, −66% to 1%), and lower degrees of disability at 90 days (common odds ratio for a better outcome vs placebo, 2.44; 95% CI, 1.76 to 5.00). Conclusions and Relevance In acute ischemic stroke, 0.2 mg/kg of ApTOLL administered within 6 hours of onset in combination with EVT was safe and associated with a potential meaningful clinical effect, reducing mortality and disability at 90 days compared with placebo. These preliminary findings await confirmation from larger pivotal trials.
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| 7. |
- Johansson, Dongni, 1988, et al.
(författare)
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Evaluation of a sensor algorithm for motor state rating in Parkinson's disease
- 2019
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Ingår i: Parkinsonism & Related Disorders. - : Elsevier BV. - 1353-8020 .- 1873-5126. ; 64:July, s. 112-117
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: A treatment response objective index (TRIS) was previously developed based on sensor data from pronation-supination tests. This study aimed to examine the performance of TRIS for medication effects in a new population sample with Parkinson's disease (PD) and its usefulness for constructing individual dose-response models. Methods: Twenty-five patients with PD performed a series of tasks throughout a levodopa challenge while wearing sensors. TRIS was used to determine motor changes in pronation-supination tests following a single levodopa dose, and was compared to clinical ratings including the Treatment Response Scale (TRS) and six sub-items of the UPDRS part III. Results: As expected, correlations between TRIS and clinical ratings were lower in the new population than in the initial study. TRIS was still significantly correlated to TRS (r(s) = 0.23, P < 0.001) with a root mean square error (RMSE) of 1.33. For the patients (n = 17) with a good levodopa response and clear motor fluctuations, a stronger correlation was found (r(s) = 0.38, RMSE = 1.29, P < 0.001). The mean TRIS increased significantly when patients went from the practically defined off to their best on state (P = 0.024). Individual dose-response models could be fitted for more participants when TRIS was used for modelling than when TRS ratings were used. Conclusion: The objective sensor index shows promise for constructing individual dose-response models, but further evaluations and retraining of the TRIS algorithm are desirable to improve its performance and to ensure its clinical effectiveness.
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| 8. |
- Johansson, Dongni, 1988, et al.
(författare)
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Individualization of levodopa treatment using a microtablet dispenser and ambulatory accelerometry
- 2018
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Ingår i: CNS Neuroscience & Therapeutics. - : Wiley. - 1755-5930 .- 1755-5949. ; 24:5, s. 439-447
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Tidskriftsartikel (refereegranskat)abstract
- Aim: This 4-week open-label observational study describes the effect of introducing a microtablet dose dispenser and adjusting doses based on objective free-living motor symptom monitoring in individuals with Parkinson's disease (PD). Methods: Twenty-eight outpatients with PD on stable levodopa treatment with dose intervals of ≤4 hour had their daytime doses of levodopa replaced with levodopa/carbidopa microtablets, 5/1.25 mg (LC-5) delivered from a dose dispenser device with programmable reminders. After 2 weeks, doses were adjusted based on ambulatory accelerometry and clinical monitoring. Results: Twenty-four participants completed the study per protocol. The daily levodopa dose was increased by 15% (112 mg, P < 0.001) from period 1 to 2, and the dose interval was reduced by 12% (22 minutes, P = 0.003). The treatment adherence to LC-5 was high in both periods. The MDS-UPDRS parts II and III, disease-specific quality of life (PDQ-8), wearing-off symptoms (WOQ-19), and nonmotor symptoms (NMS Quest) improved after dose titration, but the generic quality-of-life measure EQ-5D-5L did not. Blinded expert evaluation of accelerometry results demonstrated improvement in 60% of subjects and worsening in 25%. Conclusions: The introduction of a levodopa microtablet dispenser and accelerometry aided dose adjustments improve PD symptoms and quality of life in the short term.
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| 9. |
- Johansson, Dongni, 1988, et al.
(författare)
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Tonic-clonic seizure detection using accelerometry-based wearable sensors: A prospective, video-EEG controlled study
- 2019
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Ingår i: Seizure : the journal of the British Epilepsy Association. - : Elsevier BV. - 1059-1311 .- 1532-2688. ; 65, s. 48-54
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The aim of this prospective, video-electroencephalography (video-EEG) controlled study was to evaluate the performance of an accelerometry-based wearable system to detect tonic-clonic seizures (TCSs) and to investigate the accuracy of different seizure detection algorithms using separate training and test data sets. Methods: Seventy-five epilepsy surgery candidates undergoing video-EEG monitoring were included. The patients wore one three-axis accelerometer on each wrist during video-EEG. The accelerometer data was band-pass filtered and reduced using a movement threshold and mapped to a time-frequency feature space representation. Algorithms based on standard binary classifiers combined with a TCS specific event detection layer were developed and trained using the training set. Their performance was evaluated in terms of sensitivity and false positive (FP) rate using the test set. Results: Thirty-seven available TCSs in 11 patients were recorded and the data was divided into disjoint training (27 TCSs, three patients) and test (10 TCSs, eight patients) data sets. The classification algorithms evaluated were K-nearest-neighbors (KNN), random forest (RF) and a linear kernel support vector machine (SVM). For the TCSs detection performance of the three algorithms in the test set, the highest sensitivity was obtained for KNN (100% sensitivity, 0.05 FP/h) and the lowest FP rate was obtained for RF (90% sensitivity, 0.01 FP/h). Conclusions: The low FP rate enhances the clinical utility of the detection system for long-term reliable seizure monitoring. It also allows a possible implementation of an automated TCS detection in free-living environment, which could contribute to ascertain seizure frequency and thereby better seizure management.
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| 10. |
- Melin, Jeanette, et al.
(författare)
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Construct specification equations : ‘Recipes’ for certified reference materials in cognitive measurement
- 2021
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Ingår i: Measurement: Sensors. - : Elsevier Ltd. - 2665-9174. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Construct specification equations (CSEs), providing a comprehensive understanding of the construct purported to be measured and how a collection of items works together causally, are candidate ‘recipes for certified reference materials’ (CRM). Analogous to the role of CRMs in areas such as chemistry and material properties, CSEs appear to provide metrological traceability in the human sciences. In this work we illustrate how memory test items, Rasch Measurement Theory (RMT) and CSEs can be brought together to help ‘tell a clearer story’ about memory decline that links language- and cultural-free items (blocks, digits) to more complex word recall. Combining different test items to form novel cognitive metrics, done carefully so not jeopardize validity and to enhance coherence in item design and purpose, is guided by entropy-based equivalence criteria identified in the CSEs. The novel NeuroMET Memory Metric may enable better-informed high stakes decision-making and more efficient and valid cognitive assessment.
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