Modafinil in Debilitating Fatigue After Stroke (MIDAS)

Nothing here suggests that this was written up as a protocol and distributed to all the worlds' stroke hospitals.  I bet your stroke hospital will do nothing with this information, they will wait for SOMEONE ELSE TO SOLVE THE PROBLEM?

Your hospital takes no responsibility for finding and implementing research that will help survivors. Ask that if you don't believe me. I bet they don't have a staff person monitoring stroke research. 

I had massive fatigue immediately post stroke and continuing for years. My doctor stupidly said I needed to get more cardiovascularly fit. He never tested my cardio fitness. Three years after my stroke I had a physical where my resting heart rate was 54 at the age of 53. That means my cardiovascular fitness was that of an athlete, even after doing nothing on it for 3 years. Yet I was still completely fatigued everyday.  

Statistics on stroke fatigue:

At least half of all stroke survivors experience fatigue Or is it 70%?

Or is it 40%?

Modafinil in Debilitating Fatigue After Stroke (MIDAS)

by Dr Tom Lillicrap
Fatigue is a common, and often debilitating symptom in stroke survivors. For many patients, fatigue improves on its own over the first 2-3 months after their stroke. However, fatigue that persists beyond 3 months will often continue for many months or years afterwards. Severe fatigue interferes with a person’s ability to participate in rehabilitation activities, return to work or even just socialise with their friends and family. There are currently no proven therapies for post-stroke fatigue, but the Modafinil in Debilitating Fatigue After Stroke (MIDAS) trial aimed to remedy this by testing the drug Modafinil. Modafinil is a “wakefulness-promoting agent” which is primarily used to treat the sleeping disorder narcolepsy.
The MIDAS trial assigned patients to receive either Modafinil or placebo every day for 6 weeks, followed by a washout period to allow all the drug to leave their system, after which patients swapped treatments. This means that those who had been taking Modafinil began taking placebo, and those who had been taking placebo began taking Modafinil. Neither the patient nor the researchers knew which tablets were Modafinil and which were placebo. We performed a number of tests on patients before they started each course of tablets, and at the end of each course. These tests measured fatigue levels, quality of life and cognition.
In the results of the trial, published last year in Stroke, we found that Modafinil did effectively alleviate fatigue and improve quality of life. Even more gratifying than the statistical results (which allowed us to set up a larger phase III clinical trial) were the individual stories from patients who took part in the trial. Three patients managed to return to work which had been impossible due their level of fatigue. One of these patients had suffered his stroke after his wedding. With returning to work and having more energy, he and his wife were able to plan the honeymoon they never got to take. Another patient finally had enough energy to stay awake and leave the house in afternoon. He appreciated most being able to take his teenage daughter to lunch and to the beach, an experience she had not had with her dad for as long as she could remember.
The larger trial, MIDAS 2, is being run across multiple hospitals: The Royal Adelaide Hospital (SA), Royal Melbourne Hospital – City campus (Parkville, Victoria) and John Hunter Hospital – New Lambton (NSW). This trial may provide the evidence needed to have Modafinil listed on the PBS for post-stroke fatigue. This is an important step as the drug is quite expensive (costing around $160 per month) and for many stroke survivors, this cost is beyond their means.
The trial is registered on the Australian NewZealand Clinical Trials Registry (ACTRN12618000602224).
If you wish to participate in this trial please talk to your health care provider and refer to this information for consumers.

Breaking Up Sitting Time After Stroke Study - Australia

Join if you can. With the 85% inactivity that stroke patients have there should also be a study on:

1. action observation, 

2. mirror therapy,

3. thermal therapy, 

4. lucid dreaming 

5. Music therapy

6. Sensation overload 

to determine the efficacy of these interventions. We need protocols not just, 'Hey this seems to work sometimes, but we know nothing about dosing. You'll just have to guess.'  And then your medical staff can blame you for not recovering because you didn't do the therapy right or long enough

Breaking Up Sitting Time After Stroke Study - Australia

BUST-BP-Dose Study

Researchers at the Hunter Medical Research Institute (HMRI) are looking at the effects of reducing long periods of sitting, with regular activity breaks, to improve blood pressure in those who have had a stroke.
The BUST-BP-Dose study will monitor blood pressure and blood sugar levels in people who have had a stroke between 3 months and 10 years ago. The study will look at the amount of short activity breaks needed to improve blood pressure in stroke survivors and reduce their risk of having another stroke.
The study is being supported by a Heart Foundation Vanguard Grant, Hunter Medical Research Institute research support grant and Priority Research Centre for Stroke and Brain Injury research support grant.

Register your interest

To find out more or to register your interest please contact Dr Gary Crowfoot on 02 40420759 (Gary.Crowfoot@newcastle.edu.au) or Mr Paul Mackie on 0420881472 (Paul.I.Mackie@uon.edu.au).

The Effects of Implicit and Explicit Motor Learning in Gait Rehabilitation of People After Stroke: Protocol for a Randomized Controlled Trial

A research study for walking for you, you will need to know Dutch.  I don't know what implicit vs. explicit means in this case.
The Effects of Implicit and Explicit Motor Learning in Gait Rehabilitation of People After Stroke: Protocol for a Randomized Controlled Trial

Stop Thinking Positively

I'm not focusing on the goal of solving all the problems in stroke. I'm just doing my small part of pointing out that the solutions are out there if thousands of research trials are followed up to create stroke protocols from them. If I can influence one stroke survivor each month to demand their doctor contact a researcher to get a clinical trial going, it will snowball and pretty soon the answers will start rolling in. My audience is 10 million survivors a year, even a 1% success rate is a lot of contacts. The stroke medical world will collapse under 10 million yearly stroke survivors  screaming.

Stop Thinking Positively

Alex Korb Ph.D. PreFrontal Nudity

Stop Thinking Positively

The secret to accomplishing the impossible.

Posted Oct 19, 2015

Last month in New York, the obscure and aging Roberta Vinci faced No. 1 ranked Serena Williams in the semi-finals of the U.S. Open. While Vinci had had a lot of success in doubles tennis over the years, she had never before even reached the semi-finals of a major tournament in singles in her entire career. By contrast, Serena had already won three majors that year, and was considered one of the greatest tennis players of all time who was still playing at the top of her game. Vinci was a 300-to-1 underdog. No one gave her a shot at winning.

Source: Alex Korb

And yet she won.
In the post-match interview, she was asked, “When you woke up this morning, what gave you the belief that this moment was possible?”
She replied simply, “No,” and laughed. No, no, no. She did not think it was possible, so she tried not to think about it. “In my mind I say, ‘put the ball on the court’,” Vinci explained. “Don’t try and think and put all the ball[s] on the court. Don’t think that Serena is in the other court. And run.” She laughed. “Put the ball and run. Don’t think, and run. And then I won.”
Vinci’s attitude cuts strongly against today’s happiness and positivity obsessed culture. If you’re feeling like something is impossible, then you’re told that you’re just not thinking positive enough. You’re supposed to visualize yourself winning. You have to think that you’re destined to win, or you’ll fail miserably. And, yes, for some people, in certain situations that’s enough. But it doesn’t always work. If you really believe that something is impossible, or that you won’t succeed, then trying to convince yourself otherwise can increase your anxiety, and actually get in your way.
Sometimes the best way to reach a difficult goal is to stop trying to convince yourself that it’s possible, and just take things one step at a time. As Timothy Gallwey writes in his classic sports psychology book, The Inner Game of Tennis, “When one is emotionally attached to results that he can’t control, he tends to become anxious, and then try too hard. But one can control the effort he puts into winning. One can always do the best he can at any given moment. Since it is impossible to feel anxiety about an event that one can control, the mere awareness that you are using maximum effort to win each point will carry you past the problem of anxiety.”
Focusing on the effort, rather than the goal can help keep your brain from getting in your own way. Part of the reason this works is because being more highly motivated to accomplish a goal actually increases the brain’s response to errors (Bengtsson, 2009). The more important a goal becomes, the more a mistake will trigger the brain region that sits at the center of attention and emotion, the anterior cingulate. That increased anterior cingulate activity is intended to keep you focused on doing a good job, but it can become a problem if your brain’s response to errors becomes so large that it’s distracting.
So if a goal intimidates you, stop focusing on it. If a goal seems impossible, stop trying to “accomplish” it. I’m sure the phrase, “be in the moment” has been shoved in your face a million times. Well that’s what that means. Thinking about the goal is not being in the present. The goal is somewhere off in the future. Forget about it. Just hit the ball, and run.
REFERENCES
Bengtsson SL et al (2009) “Motivation to do Well Enhances Responses to Errors and Self-Monitoring” Cerebral Cortex
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Ageism in stroke rehabilitation studies

Our fucking failures of stroke associations should have been on top of this problem and prevented it from happening. But they really have nothing to do with stroke at all, just lazy press release organizations.  I can see no one enforcing this recommendation until we get that great stroke association established. Once again describing a problem but offering no solution. 

Ageism in stroke rehabilitation studies

Eva Joan Gaynor Sheena Elizabeth Geoghegan Desmond O'Neill

Age and Ageing, Volume 43, Issue 3, 1 May 2014, Pages 429–431, https://doi.org/10.1093/ageing/afu026

Published:

18 March 2014

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Abstract

Background: stroke is predominantly a disease of older people. While age bias has been demonstrated in studies of pharmacological therapeutic interventions in stroke, the extent of discrimination by age in stroke rehabilitation studies is unknown. The aim of this study was to systematically review the literature to assess the extent of ageism in stroke rehabilitation studies.
Methods: all randomised control trials (RCT) on stroke rehabilitation entered in the Cochrane database which reported mean age were included. Patient gender and exclusion criteria were also recorded.
Results: of 241 RCT's identified, 182 were eligible for inclusion. The mean age of all patients was 64.3, almost a decade younger than those seen by stroke physicians in daily practice in global terms, and 11–12 years younger than encountered in hospital practice in the British Isles. Almost half (46%) of trials excluded patients with cognitive impairment, almost one-quarter (23%) patients with dysphasia and one-eighth (13%) excluded patients with multiple strokes.
Conclusion: we have identified a clear difference in the mean age of those included in stroke rehabilitation studies compared with the international mean age of stroke. In addition, a quarter of trials excluded dysphasic patients which may indicate omission of more severe strokes. This means that the evidence base for stroke rehabilitation is deficient in terms of matching the characteristics of patients encountered in clinical practice, and a more representative sample of older people and those with significant disability must be included in future trials.

Introduction

Stroke is not only an illness of major global significance—15 million people suffer stroke worldwide each year, of which 5 million people die and a further 5 million are permanently disabled [1]—but is also predominantly a disease of older people. The average age of patients admitted to hospital each year with stroke in Ireland is 75 [2]. These figures are comparable with the United Kingdom National Stroke Audits that reports a mean age of 75.8 [3].
Existing research shows evidence of ageism in the clinical management of older people with acute stroke [4]. Ageism is also evident in the design and implementation of pharmacological, mechanical and surgical interventional research studies in stroke [5]. This needs to be addressed given the ensuing paradox that the treatments will be given mostly to older people among whom efficacy and safety has not been adequately assessed.
Rehabilitation is another critical component of recovery for many stroke survivors. While there is significance evidence of the efficacy of post-acute rehabilitation in reducing mortality and dependency of stroke patients [6], with post-stroke rehabilitation an ever-increasing focus of interest [7], it is not clear to what extent the populations of participants in these studies mirror the age profile of patients encountered in clinical practice.
We undertook a review of the current literature to evaluate whether ageism is also a feature in the design of studies in stroke rehabilitation. In addition, although all patients with stroke, except for those who either make a rapid and complete recovery or else die in the immediate aftermath, should benefit from rehabilitation, it is also not clear as to what proportion of those with more complex strokes has been excluded from trials of rehabilitation.
We analysed the mean ages, exclusion criteria and gender ratios of trials related to stroke rehabilitation included in the Cochrane Collaboration Reviews, given that these are a key reference point in evidence-based medicine.

More at link. 

Down-regulation of Nogo-A by collagen scaffolds impregnated with bone marrow stromal cell treatment after traumatic brain injury promotes axonal regeneration in rats

WHOM the hell is going to start testing this in humans?

Down-regulation of Nogo-A by collagen scaffolds impregnated with bone marrow stromal cell treatment after traumatic brain injury promotes axonal regeneration in rats

• Asim Mahmood^{a, , , ,} ,
• Hongtao Wu^a, ,
• Changsheng Qu^a, ,
• Selina Mahmood^a, ,
• Ye Xiong^a, ,
• David Kaplan^d, ,
• Michael Chopp^{b, c,}

• ^a Department of Neurosurgery, 2799W Grand Blvd, Henry Ford Hospital, Detroit, MI, 48202 USA
• ^b Department of Neurology, 2799W Grand Blvd, Henry Ford Hospital, Detroit, MI, 48202 USA
• ^c Department of Physics, Oakland University, 2200 North Squirrel Road, Rochester, MI, 48309-4401 USA
• ^d Department of Biomedical Engineering, Science and Technology Center, Room 251, Tufts University, Boston, MA, 02155 USA

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Highlights

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Human bone marrow stromal cells were impregnated into scaffolds for transplantation.

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Scaffold+hMSC treatment reduced Nogo-A protein level in the injured brain.

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Scaffold+hMSC treatment down-regulated Nogo-A gene transcription in oligodendrocytes.

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Scaffold+hMSC treatment increased axonal density after TBI.

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Abstract

Nogo-A is a major form of growth inhibitory molecule (growth-IM) which inhibits axonal regeneration and neurite regrowth after neural injury. Bone marrow stromal cells (MSCs) have been shown to inhibit Nogo-A expression in vitro and in cerebral ischemic animal models. The present study was designed to investigate the effects of treatment with human MSCs (hMSCs) impregnated into collagen scaffolds on the expression of Nogo-A and axonal plasticity after traumatic brain injury (TBI). Adult male Wistar rats were injured with controlled cortical impact and treated either with saline, hMSCs-alone or hMSCs impregnated into collagen scaffolds (scaffold+hMSC) transplanted into the lesion cavity 7 days after TBI. Rats were sacrificed 14 days after TBI and brain tissues were harvested for immunohistochemical studies, Western blot analysis, laser capture microdissections and qRT-PCR to evaluate axonal density and Nogo-A protein and gene expressions. Our data showed that treatment of TBI with scaffold+hMSC significantly decreased TBI-induced Nogo-A protein expression and increased axonal density compared to saline and hMSC-alone treatments. In addition, scaffold+hMSC transplantation decreased Nogo-A transcription in oligodendrocytes after TBI. Scaffold +hMSC treatment was superior to hMSC-alone treatment in suppressing Nogo-A expression and enhancing axonal regeneration after TBI. Our data suggest that transplanting hMSCs with scaffolds down-regulates Nogo-A transcription and protein expression which may partially contribute to the enhanced axonal regeneration after TBI.

Unique Experiences with Intercontinental Trials in Stroke - Part II

One part applies to me. I may have to see a doctor and explain to him/her why this research needs to be read in detail to prevent my next stroke.

Unique Experiences with Intercontinental Trials in Stroke - Part II

PDF (211.9 KB)HTML

Authors

H. J. M. Barnett¹, John (Jack) Coleman Laidlaw¹

¹University of Toronto, Toronto, Ontario, Canada

Abstract

Supported by the Canadian Medical Research Council we performed a randomized trial extending from Newfoundland to British Columbia. With others a number of observations showed that aspirin will reduce stroke. With National Institute of Neurological Disorders and Stroke support we learned who would benefit and not from surgery in these stroke threatened carotid diseased patients. We evaluated the upper limits of acceptability of complications beyond which harm was done. Amassing this large data base of approximately 5000 individuals, followed for five years, previously unknown carotid phenomena were observed: 1. Ischemic stroke occurs in patients with prolapsing mitral valves; 2. There is risk of stroke in patients with residual thrombi in the occluded stump of the carotid artery; 3. We detected a lower risk than expected in patients with nearly occluded carotid arteries. We support the contention of Yusuf and Cairns' that Canada needs to give more financial support to purely clinical research. It pays off !

Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial

When are we going to get these research trials translated into stroke protocols? This is something any good stroke association would be doing. But we don't even have a piss poor stroke association for survivors. We don't have any association that is dedicated to survivors unless we can convince the existing ones(that's you, board of directors) to do the right thing.
http://www.jneuroengrehab.com/content/10/1/85

Abstract

Background

Recent evidence has demonstrated the efficacy of Virtual Reality (VR) for stroke rehabilitation nonetheless its benefits and limitations in large population of patients have not yet been studied.

Objectives

To evaluate the effectiveness of non-immersive VR treatment for the restoration of the upper limb motor function and its impact on the activities of daily living capacities in post-stroke patients.

Methods

A pragmatic clinical trial was conducted among post-stroke patients admitted to our rehabilitation hospital. We enrolled 376 subjects who had a motor arm subscore on the Italian version of the National Institutes of Health Stroke Scale (It-NIHSS) between 1 and 3 and without severe neuropsychological impairments interfering with recovery. Patients were allocated to two treatments groups, receiving combined VR and upper limb conventional (ULC) therapy or ULC therapy alone. The treatment programs consisted of 2 hours of daily therapy, delivered 5 days per week, for 4 weeks. The outcome measures were the Fugl-Meyer Upper Extremity (F-M UE) and Functional Independence Measure (FIM) scales.

Results

Both treatments significantly improved F-M UE and FIM scores, but the improvement obtained with VR rehabilitation was significantly greater than that achieved with ULC therapy alone. The estimated effect size of the minimal difference between groups in F-M UE and FIM scores was 2.5 ± 0.5 (P < 0.001) pts and 3.2 ± 1.2 (P = 0.007) pts, respectively.

Conclusions

VR rehabilitation in post-stroke patients seems more effective than conventional interventions in restoring upper limb motor impairments and motor related functional abilities.

A critical look at the difficulty of publishing “negative” results

This might help in explaining the negative results causing 636 deaths in stroke studies.
http://scopeblog.stanford.edu/2012/05/a-critical-look-at-the-difficulty-of-publishing-negative-results/

Useful stroke trials left unpublished

What can I say? Stupid, stupid, stupid.
http://www.alphagalileo.org/ViewItem.aspx?ItemId=74174&CultureCode=en
An investigation into unpublished stroke research data has revealed that 19.6% of completed clinical trials, which could potentially influence patient care, are not published in full. Researchers writing in BioMed Central’s open access journal Trials describe how these unpublished studies included more than 16,000 participants and tested 89 different interventions.
Peter Sandercock and his colleague Lorna Gibson worked with a team of researchers from the University of Edinburgh, UK, to search the Cochrane Stroke Group’s Specialised Register of Trials for completed trials of pharmacological interventions for acute ischemic stroke, and to determine how many of these were ultimately published. He said, “Failure to publish trial data is to be deprecated as it sets aside the altruism of participants’ consent to be exposed to the risks of experimental interventions, potentially biases the assessment of the effects of therapies, and may lead to premature discontinuation of research into promising treatments”.
The researchers identified 940 trials, of which 125 were not published in full. The largest trial included 856 patients, while two unpublished trials included fewer than 10 patients each. According to Sandercock, “Several of the trials we identified may have been large enough to influence clinical practice and the findings of systematic reviews and meta-analyses”.
Sandercock concludes, “Well designed clinical trials should be published because their results can benefit patients, justifying the risk to trial participants from experimental treatments. We found 22 unpublished trials that reported the number of deaths. In these trials, 636 people died, but no information was available on whether the experimental drug had contributed to any of those deaths”.
551 different researchers were involved in conducting these studies and of these, 72 had been involved in more than one trial that remained unpublished.