| 1. |
- Ekman, Urban, et al.
(author)
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Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI) : Study Protocol of a Randomized Controlled Trial
- 2020
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In: Frontiers in Psychology. - : Frontiers Media SA. - 1664-1078. ; 11
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Journal article (peer-reviewed)abstract
- Background: Individuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues (including symptoms of stress, anxiety, and depression). The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention (Psychological Intervention tailored for Patients with Cognitive Impairment, PIPCI) manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial (RCT)-design and methods. The main hypothesis is that participants receiving PIPCI will increase their psychological flexibility (the ability to notice and accept interfering thoughts, emotions, and bodily sensations without acting on them, when this serves action in line with personal values) compared to participants in the active control (cognitive training) group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health (stress measures, quality of life, depression, and general health) compared to participants in the active control group and the waiting list control group.Materials and Methods: This three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group (psychological intervention once a week for 10 weeks), an active control group (cognitive training once a week for 10 weeks) or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers (obtained from blood and saliva) and health care costs. Assessments will be performed at pre- (1 week before the interventions) and post-intervention (1 week after the interventions), as well as at a 6-month follow-up.Discussion: The development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment (PIPCI) has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.
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| 2. |
- Pressler, Ronit M., et al.
(author)
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Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO) : an open-label, dose finding, and feasibility phase 1/2 trial
- 2015
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In: Lancet Neurology. - 1474-4422 .- 1474-4465. ; 14:5, s. 469-477
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Journal article (peer-reviewed)abstract
- Background Predinical data suggest that the loop-diuretic bumetanide might be an effective treatment for neonatal seizures. We aimed to assess dose and feasibility of intravenous bumetanide as an add-on to phenobarbital for treatment of neonatal seizures. Methods In this open-label, dose finding, and feasibility phase 1/2 trial, we recruited full-term infants younger than 48 h who had hypoxic ischaemic encephalopathy and electrographic seizures not responding to a loading-dose of phenobarbital from eight neonatal intensive care units across Europe. Newborn babies were allocated to receive an additional dose of phenobarbital and one of four bumetanide dose levels by use of a bivariate Bayesian sequential dose-escalation design to assess safety and efficacy. We assessed adverse events, pharmacokinetics, and seizure burden during 48 h continuous electroencephalogram (EEG) monitoring. The primary efficacy endpoint was a reduction in electrographic seizure burden of more than 80% without the need for rescue antiepileptic drugs in more than 50% of infants. The trial is registered with ClinicalTrials.gov, number NCT01434225. Findings Between Sept 1, 2011, and Sept 28, 2013, we screened 30 infants who had electrographic seizures due to hypoxic ischaemic encephalopathy. 14 of these infants (10 boys) were included in the study (dose allocation: 0.05 mg/kg, n=4; 0.1 mg/kg, n=3; 0. 2 mg/kg, n=6; 0.3 mg/kg, n=1). All babies received at least one dose of bumetanide with the second dose of phenobarbital; three were withdrawn for reasons unrelated to bumetanide, and one because of dehydration. All but one infant also received aminoglycosides. Five infants met EEG criteria for seizure reduction (one on 0.05 mg/kg, one on 0.1 mg/kg and three on 0.2 mg/kg), and only two did not need rescue antiepileptic drugs (ie, met rescue criteria; one on 0.05 mg/kg and one on 0.3 mg/kg). We recorded no short-term dose-limiting toxic effects, but three of 11 surviving infants had hearing impairment confirmed on auditory testing between 17 and 108 days of age. The most common non-serious adverse reactions were moderate dehydration in one, mild hypotension in seven, and mild to moderate electrolyte disturbances in 12 infants. The trial was stopped early because of serious adverse reactions and limited evidence for seizure reduction. Interpretation Our findings suggest that bumetanide as an add-on to phenobarbital does not improve seizure control in newborn infants who have hypoxic ischaemic encephalopathy and might increase the risk of hearing loss, highlighting the risks associated with the off-label use of drugs in newborn infants before safety assessment in controlled trials.
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| 3. |
- Rennie, Linda, et al.
(author)
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The reliability of gait variability measures for individuals with Parkinson's disease and healthy older adults - The effect of gait speed.
- 2018
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In: Gait & posture. - : Elsevier BV. - 1879-2219 .- 0966-6362. ; 62, s. 505-509
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Journal article (peer-reviewed)abstract
- Step-to-step variability is a marker of reduced motor control and a frequently studied outcome measure in neurodegenerative disorders such as Parkinson's disease (PD) as compared to healthy older adults (HOA). To challenge motor control of gait, walking should be tested at different gait speeds. Good reliability is essential, and gait variability estimates show good reproducibility when sampled at normal gait speed. The aim was therefore to investigate if gait variability could be reliably sampled at slow and fast speeds for individuals with PD and HOA by evaluating test-retest reliability.29 (14 males) subjects with idiopathic PD, Hoehn &Yahr 2 (n=18) and 3,≥60years, and 25 age matched HOAwere included. Spatiotemporal gait data was collected (GAITRite) during slow, normal, and fast walking on two occasions.Measurement error was lowest for gait variability estimates based on 40 steps in both groups. This was true across all speeds in HOA, but only for normal and fast gait speeds in the PD cohort. Due to increased homogeneity in the variability estimates intraclass correlation coefficients (ICC) were low for HOA, except for step width variability. In the PD cohort ICCs were good to excellent for temporal- and step width gait variability across speeds.HOA demonstrated reliable gait variability estimates across all speeds, whereas Individuals with PD were reliable at normal and fast gait speeds only Estimates should be based on at least 40 steps. Step width variability was overall the most reliable variable across groups and speed conditions.
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| 4. |
- Rennie, Linda, et al.
(author)
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The validity of the Gait Variability Index for individuals with mild to moderate Parkinson's disease.
- 2017
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In: Gait & posture. - : Elsevier BV. - 1879-2219 .- 0966-6362. ; 54, s. 311-317
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Journal article (peer-reviewed)abstract
- Increased step-to-step variability is a feature of gait in individuals with Parkinson's disease (PD) and is associated with increased disease severity and reductions in balance and mobility. The Gait Variability Index (GVI) quantifies gait variability in spatiotemporal variables where a score ≥100 indicates a similar level of gait variability as the control group, and lower scores denote increased gait variability. The study aim was to explore mean GVI score and investigate construct validity of the index for individuals with mild to moderate PD. 100 (57 males) subjects with idiopathic PD, Hoehn & Yahr 2 (n=44) and 3, and ≥60 years were included. Data on disease severity, dynamic balance, mobility and spatiotemporal gait parameters at self-selected speed (GAITRite) was collected. The results showed a mean overall GVI: 97.5 (SD 11.7) and mean GVI for the most affected side: 94.5 (SD 10.6). The associations between the GVI and Mini- BESTest and TUG were low (r=0.33 and 0.42) and the GVI could not distinguish between Hoehn & Yahr 2 and 3 (AUC=0.529, SE=0.058, p=0.622). The mean GVI was similar to previously reported values for older adults, contrary to consistent reports of increased gait variability in PD compared to healthy peers. Therefore, the validity of the GVI could not be confirmed for individuals with mild to moderate PD in its current form due to low associations with validated tests for functional balance and mobility and poor discriminatory ability. Future work should aim to establish which spatiotemporal variables are most informative regarding gait variability in individuals with PD.
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