Effect of the monoaminergic stabiliser (−)-OSU6162 on mental fatigue following stroke or traumatic brain injury

2020 ◽  
Vol 32 (6) ◽  
pp. 303-312
Author(s):  
Marie K.L. Nilsson ◽  
Birgitta Johansson ◽  
Maria L. Carlsson ◽  
Robert C. Schuit ◽  
Lars Rönnbäck
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Rating Scale ◽  
Activity Index ◽  
Principal Component ◽  
Mental Fatigue ◽  
Activity Level ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Good Tolerability

AbstractObjective:The purpose of the present study was to evaluate the efficacy and safety of (−)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from mental fatigue following stroke or traumatic brain injury (TBI).Methods:This 4 + 4 weeks double-blind randomised cross-over study included 30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least 12 months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes [Comprehensive Psychopathological Rating Scale (CPRS)], the Frenchay Activity Index (FAI), and a battery of neuropsychological tests. Safety was evaluated by recording spontaneously reported adverse events (AEs).Results:There were significant differences on the patients’ total FAI scores (p = 0.0097), the subscale FAI outdoor scores (p = 0.0243), and on the trail making test (TMT-B) (p = 0.0325) in favour of (−)-OSU6162 treatment. Principal component analysis showed a clear overall positive treatment effect in 10 of 28 patients; those who responded best to treatment had their greatest improvements on the MFS. Reported AEs were mild or moderate in severity and did not differ between the (−)-OSU6162 and the placebo period.Conclusion:The most obvious beneficial effects of (−)-OSU6162 were on the patients’ activity level, illustrated by the improvement on the FAI scale. Moreover, a subgroup of patients showed substantial improvements on the MFS. Based on these observed therapeutic effects, in conjunction with the good tolerability of (−)-OSU6162, this compound may offer promise for treating at least part of the symptomatology in patients suffering from stroke- or TBI-induced mental fatigue.

Placebo-controlled cross-over study of the monoaminergic stabiliser (−)-OSU6162 in mental fatigue following stroke or traumatic brain injury

2012 ◽  
Vol 24 (5) ◽  
pp. 266-274 ◽  
Author(s):  
Birgitta Johansson ◽  
Arvid Carlsson ◽  
Maria L. Carlsson ◽  
Magdalena Karlsson ◽  
Marie K.L. Nilsson ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Statistical Significance ◽  
Principal Component ◽  
Mental Fatigue ◽  
Self Assessment ◽  
Double Blind ◽  
Positive Treatment ◽  
Secondary Endpoints ◽  
Returning To Work

Objective: Mental fatigue occurring after a stroke or traumatic brain injury (TBI) often results in difficulties returning to work and pursuing social activities. No effective treatment of this condition is available today. In this study, we have tested a novel pharmacological strategy using the monoaminergic stabiliser (−)-OSU6162.Methods: (−)-OSU6162 was given orally for 4 weeks in doses increasing from 15 to 45 mg b.i.d. to 12 patients suffering from mental fatigue, following upon stroke (n=6) or TBI (n=6). (−)-OSU6162 was compared with placebo using a double-blind, randomised cross-over design. Patients included were well rehabilitated physically with no gross impairment in cognitive functions other than those related to the mental fatigue.Results: (−)-OSU6162 caused a remarkable improvement in mental stamina, as evaluated by a self-assessment scale on mental fatigue. Statistical significance was reached on the primary endpoint (Mental Fatigue Scale). There was a trend towards improvement in the secondary endpoints processing speed and attention. Principal component analysis showed an overall positive treatment effect in 7 of 12 patients. Beneficial responses were seen already during the first few days of active drug treatment. Increasing dosage caused no further improvement. Adverse reactions consisted of short-lasting mild nausea and attenuated appetite. These side effects disappeared upon dose reduction.Conclusion: The monoaminergic stabiliser (−)-OSU6162 offers promise as a candidate for treatment of mental fatigue after a stroke or TBI.

Ultrasound-Guided Injection of Dextrose Versus Corticosteroid in Chronic Plantar Fasciitis Management: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 193864002098092
Author(s):  
Gholamreza Raissi ◽  
Amin Arbabi ◽  
Maryam Rafiei ◽  
Bijan Forogh ◽  
Arash Babaei-Ghazani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plantar Fasciitis ◽  
Rating Scale ◽  
Corticosteroid Injection ◽  
Treatment Options ◽  
Plantar Fascia ◽  
Numeric Rating Scale ◽  
Therapeutic Effects ◽  
Ultrasound Guided ◽  
Double Blind

Design Chronic plantar fasciitis (PF) is a common cause of chronic heel pain, with different conventional treatment options. In this randomized clinical trial, the effect of ultrasound-guided injection of dextrose versus corticosteroid in chronic PF was evaluated and compared. Methods A total of 44 patients suffering from chronic PF who visited the physical medicine and rehabilitation clinic were enrolled in the study. Two table-randomized groups were formed. They received an ultrasonography-guided, single injection of either 40 mg methylprednisolone or 20% dextrose. Numeric Rating Scale (NRS), Foot and Ankle Ability Measure questionnaire with 2 subscales, Activities of Daily Living (FAAM-A) and Sports (FAAM-S), along with ultrasonographic parameters were evaluated before and at 2 and 12 weeks after the injection. Results. A total of 40 participants completed the study. Both interventions significantly improved pain and function at 2 and 12 weeks postinjection. After 2 weeks, compared with the dextrose prolotherapy, the corticosteroid group had significantly lower daytime and morning NRS scores (2.55 vs 4.1, P = .012, and 2.75 vs 4.65, P = .004), higher FAAM-S (66.84 vs 54.19; P = .047), and lower plantar fascia thickness at insertion and 1 cm distal to the insertion zone (3.89 vs 4.29 mm, P = .004, and 3.13 vs 3.48 mm, P = .002), whereas FAAM-A was similar in both groups ( P = .219). After 12 weeks, all study variables were statistically similar between corticosteroid and dextrose prolotherapy groups. No injection-related side effects were recorded in either group. Conclusion Both methods are effective. Compared with dextrose prolotherapy, our results show that corticosteroid injection may have superior therapeutic effects early after injection, accompanied by a similar outcome at 12 weeks postinjection. Levels of Evidence: Level II

scholarly journals Age, Sex and Cerebral Microbleed Effects On White Matter Degradation After Traumatic Brain Injury

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 886-887
Author(s):  
Andrei Irimia ◽  
Ammar Dharani ◽  
Van Ngo ◽  
David Robles ◽  
Kenneth Rostowsky
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
White Matter ◽  
Diffusion Tensor ◽  
Diffuse Axonal Injury ◽  
Principal Component ◽  
Older Age ◽  
Analysis Of Covariance ◽  
Future Research ◽  
Cerebral Microbleed

Abstract Mild traumatic brain injury (mTBI) affects white matter (WM) integrity and accelerates neurodegeneration. This study assesses the effects of age, sex, and cerebral microbleed (CMB) load as predictors of WM integrity in 70 subjects aged 18-77 imaged acutely and ~6 months after mTBI using diffusion tensor imaging (DTI). Two-tensor unscented Kalman tractography was used to segment and cluster 73 WM structures and to map changes in their mean fractional anisotropy (FA), a surrogate measure of WM integrity. Dimensionality reduction of mean FA feature vectors was implemented using principal component (PC) analysis, and two prominent PCs were used as responses in a multivariate analysis of covariance. Acutely and chronically, older age was significantly associated with lower FA (F2,65 = 8.7, p < .001, η2 = 0.2; F2,65 = 12.3, p < .001, η2 = 0.3, respectively), notably in the corpus callosum and in dorsolateral temporal structures, confirming older adults’ WM vulnerability to mTBI. Chronically, sex was associated with mean FA (F2,65 = 5.0, p = 0.01, η2 = 0.1), indicating males’ greater susceptibility to WM degradation. Acutely, a significant association was observed between CMB load and mean FA (F2,65 = 5.1, p = 0.009, η2 = 0.1), suggesting that CMBs reflect the acute severity of diffuse axonal injury. Together, these findings indicate that older age, male sex, and CMB load are risk factors for WM degeneration. Future research should examine how sex- and age-mediated WM degradation lead to cognitive decline and connectome degeneration after mTBI.

The effects of amantadine on traumatic brain injury outcome: a double-blind, randomized, controlled, clinical trial

Brain Injury ◽  
2018 ◽  
Vol 32 (8) ◽  
pp. 1050-1055 ◽  
Author(s):  
Hossein Ghalaenovi ◽  
Arash Fattahi ◽  
Jalil Koohpayehzadeh ◽  
Mahmoud Khodadost ◽  
Neda Fatahi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled
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