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Parkinson’s trial investigates tavapadon possibilities

Cerevel Therapeutics, a firm aimed at unraveling the mysteries of the brain to treat neuroscience diseases, has announced a new Parkinson’s trial.

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The company is evaluating the use of tavapadon in patients with Parkinson’s disease.

Tavapadon is a potent, orally-bioavailable, selective partial agonist of the dopamine D1 and D5 receptors.

It is being evaluated as a once-daily symptomatic treatment of Parkinson’s disease.

Cerevel will conduct three 27-week trials designed to evaluate the efficacy, safety and tolerability of fixed doses and flexible doses of tavapadon; as either a single  therapy in patients with early-stage Parkinson’s disease or as an adjunctive one in patients with late-stage Parkinson’s experiencing motor fluctuations.

A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

“Parkinson’s disease affects approximately 10 million people worldwide, and there remains an important need for better and more effective therapies across the spectrum of this debilitating disease,” says Raymond Sanchez, chief medical officer of Cerevel Therapeutics.

“We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage Parkinson’s. It is our expectation that the innovative design of each of these Phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning. We anticipate data from these trials to be available beginning in the second half of 2022.”

The three double-blind, randomized, placebo-controlled, parallel-group Phase 3 clinical trials will enroll patients ages 40 to 80 years with either early-stage Parkinson’s disease (TEMPO-1, TEMPO-2) or patients with late-stage Parkinson’s disease who are experiencing motor fluctuations on levodopa treatment (TEMPO-3).

Approximately 1,200 patients will be enrolled across all three trials.

Approximately 10 million people worldwide are living with Parkinson’s disease, according to the Parkinson’s Foundation.

The disease is characterised by a progressive degeneration of dopaminergic neurons (the main source of dopamine) leading to a loss of critical motor and non-motor functions.

Symptom severity and disease progression differ between individuals but typically include slowness of movement (bradykinesia), trembling in the extremities (tremors), stiffness (rigidity), cognitive or behavioral abnormalities, sleep disturbances and sensory dysfunction.1

There is no laboratory or blood test for Parkinson’s disease, so a diagnosis is made based on clinical observation,2 which may contribute to an underestimation of the incidence of the disease.

Cerevel Therapeutics seeks to unlock the science surrounding new treatment opportunities through understanding the neurocircuitry of neuroscience diseases and associated symptoms

It has a pipeline comprising five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia and substance use disorder.

The firm is headquartered in Boston, US.

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What’s a Duchess without a G&T darling?”

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Laura Nicholls, lead speech and language therapist at The Bridge Neurological Care Centre in Middlesbrough, reflects on the rehabilitative journey of her patient Angela on regaining some normality following a lengthy admission in intensive care.

Firstly there’s a couple of things you need to know about Angela before I can tell you about her journey. She isn’t usually one to let another person speak for her but I have been given full permission to share with you all the ups and downs of her rehabilitative journey.

Angela has acquired the very fitting nickname ‘The Duchess’. This comes from her previous occupation as a community matron, her fine eye for detail, her drive for perfection and her tendency towards bossiness.

In April 2019 Angela was admitted to hospital with Myasthenia Gravis that resulted in Myasthenic crisis (respiratory failure).

Myasthenia Gravis is
a rare long-term neurological condition that causes muscle weakness.

In Angela’s case she experienced severe difficulty swallowing, loss of voice (aphonia) and severe breathing problems.

This resulted in the insertion of a tracheostomy (an opening created at the front of the neck so a tube can be inserted into the windpipe/ trachea to help you breathe) with 24/7 ventilation to assist with breathing.

This emergency procedure can often cause weakness and structural damage that further complicates an individual’s recovery of function. This means that often the long-lasting impact of having difficulty speaking, eating and drinking on someone’s quality of life is not fully realised until the months after initial survival has been achieved.

It is the role of a speech and language therapist to provide assessment, treatment and support for individuals who have difficulties with communication, or with eating drinking and swallowing.

Angela’s swallow and voice were severely affected second to muscle weakness and poor breath support. This resulted in poor airway protection when she was eating and drinking meaning food and fluids entered the trachea and lungs rather than the oesophagus leading to the stomach. This can cause serious health concerns as it can result in airway obstruction (choking), chest infections, pneumonia and death.

I worked closely with Angela to identify what was most important to her and what would make a difference to her quality of life and wellbeing. Angela identified that she would love to be able to have a gin and tonic and FaceTime her family and friends without them having difficulty hearing her.

This was a huge target for a lady who was nil by mouth with an unsafe swallow having all her nutrition and hydration needs met via a tube into her stomach (percutaneous tube) and who had a very weak voice; Angela’s friends and family would often ring her but could only have a one-sided conversation as Angela’s voice was too weak to be heard over the phone.

From thorough assessment, I created an intensive swallow and voice rehabilitation programme when Angela was discharged to us in August 2019 which utilised specific muscle building/strengthening exercises to target the areas of breakdown in her voice and swallow.

This programme focused on improving oral control and coordination, improving laryngeal elevation and hyoid excursion (good range of movement is required to swallow safely), improve airway protection, increase strength of cough and strengthen her vocal cords to increase strength of voice. Angela completed this programme multiple times per day.

Her exercises were recorded onto her iPad for her to work through daily and support her in the completion of these.

Angela’s recovery and ability to wean from ventilation was lengthy and unpredictable at times. She suffered a number of setbacks and respiratory complications during her recovery that impacted her ability to complete therapy. However she remained determined and focused on what she wanted to achieve.

By December 2019, she made significant progress. Through her dedication and perseverance with her rehabilitation programme she achieved her goals. After months of being unable to eat and drink Angela’s swallow was now safe – she was able to eat and drink without difficulty or fear of choking.

Angela’s voice was also a lot stronger, she went from being inaudible on the telephone to being intelligible 100 per cent of the time and being understood in all communication environments with no incidents of communication breakdown with familiar or unfamiliar listeners.

Angela continued with her rehabilitation programme and in February 2020 she attended her local flower club meeting where she addressed all 70 attendees, delivering a 10 minute speech without difficulty.

This was a major achievement given that she was struggling to make herself heard to one individual in a quiet room six months prior.

It was a moment of great pride when she introduced me to the audience saying: “This is Laura, my speech therapist, without whom I would not be able to speak to you all today and without whom I would not be able to enjoy this gorgeous spread you have put on for us all.”

In March 2020 the tube into Angela’s stomach was removed as she no longer needed it to meet her nutrition and hydration needs – she could do this by eating and drinking herself.

The therapy outcome measures graphs clearly show the positive outcomes she has been able to achieve through therapy, but the true outcome is written all over her face – smiling ear to ear.

Through therapy Angela did not just regain the ability to speak and swallow, she gained confidence in recovering functions that she thought she had lost forever and a new appreciation for the things in life that people often take for granted.

Angela has been a complete joy to work with and one of the greatest honours of my career has been to work alongside her.

Now enjoy your G&T Duchess – you deserve it.

Laura Nicholls is a speech and language therapist at The Bridge Neurological Care Centre in Middlesbrough, which provides specialist inpatient neurological rehabilitation and complex care for people with neurological illnesses, acquired brain and spinal cord injuries. For more info visit www.elysiumhealthcare.co.uk.

 

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Music in the key of R

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Rehabilitation journeys are increasingly being guided by the rhythmic interventions of music therapists but challenges in opening up access remain; as Chroma’s Daniel Thomas explains.

Daniel Thomas, managing director of art therapies provider Chroma, developed an interest in music at a young age. However, he’s concerned that young people today aren’t exposed to enough music education, and that this will have a knock- on effect on music therapy, which can help a range of people, including those with a brain injury.

“There have been massive cutbacks, a killing off of music in schools,” Thomas says, “Which has had a huge effect over many years as that side of school life has been systematically eked away and cut back.

“If people aren’t exposed or brought into music education early in their lives, it probably won’t happen later on in a way that’ll lead to them considering music therapy as a profession.”

“I’d be delighted if Boris Johnson and the education secretary saw the significant social value and healthcare value of having music in the education curriculum. It’s almost criminal to strip it out in the way it has been stripped out by Labour and Conservatives, and it needs to go back in as matter of national urgency.”

Chroma is a trailblazer for the government’s new arts therapy apprenticeship scheme, however, which is giving Thomas hope that more people will enter the profession in the future.

“I’m hoping a much more diverse range of candidates applying to be arts therapists will come in, but it will take ten years to see the results of that.”

There’s also a need for the NHS to spend more money on arts therapy, which also includes drama and art, he argues.

“The NHS used to be the biggest employer of arts therapy, but with various cutbacks, those jobs have gone.

“I think there are huge untapped resources within arts therapy professions, but that takes significant amounts of education.”

Thomas, however, generally feels very positive about the strides music therapy has taken in recent years.

There is a growing recognition of the power of arts therapies, he says, and in recent years, a growing body of research on how music therapy can help many groups of people with many injuries and conditions.

The Covid-19 pandemic has forced professionals in arts therapy, including the roughly 70 therapists who work for Chroma, to work together, and
move online.

“Covid has spurred on the profession and ourselves to open up our minds to other ways of working, while at the same time, holding onto core clinical ethics as therapists: are we doing no harm, and are we supporting that person to work towards the goals they feel are important?”

This could have cost benefits.

Conversations around this are easier today, because the profession is only now starting to talk more openly about the financial side of their work.

“For years, the economics side of the profession, how much you charge, was a bit taboo, therapists felt uncomfortable thinking about the financial aspect of what we do,” Thomas says.

“But the profession is catching up to itself around this, and learning from other sectors.”

Music therapy, as well as art and drama therapy, are regulated by the Health and Care Professions Council, and arts therapists are allied health professionals (AHPs), which means they’re on the same level as speech therapists, physiotherapists and many more.

Music therapists, including Chroma therapists, work within the NHS, and in private clinical practices.

Thomas says music therapists work as key components in multi-disciplinary teams (MDTs) helping the recovering of patients with brain injury. “We’re very collaborative – we want to follow MDT goals.

Because music stimulates a diverse range of brain areas and networks, it has an impact on speech and language, on the sensory motor system, cognitive function and the emotional wellbeing of the client.”

“Music therapy connects across a hugely diverse range of areas in the brain and there’s research from neuroscience around the way in which when the brain is stimulated by music new neural pathways are created.”

“It’s not necessarily fixing the part of the brain damaged in an accident, but going round those areas and reconnecting parts of the brain, that’s why people should feel really confidence in using music therapy and using music therapists as highly skilled professionals.”

Music therapy contributes to the expertise of numerous disciplines, Thomas says. Some patients will prefer to work towards their goals when music is the context through which that treatment is delivered, and there are many ways music can be used in their therapy.

For example, for a client who has issues walking, the rhythm of a song could be used to help them walk, or using the melody of a song to enable a sequence of steps to carry out a particular task, such as making a cup of tea.

A patient’s engagement with therapy can be improved by playing music they know – which is why, Thomas says, music therapy can be bespoke and person-centred.

A familiar song can be used by therapists, for example, to help connect a patient with their life before their brain injury and who they are now, bridging the gap between the two.

Slow music can also be used to help control anxiety by slowing down the heart rate. When a client shows signs of calming down to a particular piece of music, the therapist can share this with the MDT so it can be applied across the patient’s care.

“If their heartrate and breathing goes through the roof during personal care episodes, we can help work with the staff team to say that, from music therapy sessions, we can see that the client’s breathing slows and their heart rate reduces with this particular music.”

In this case, the piece of music could be played before and during personal care so that it can be reframed within the context of the music. Overall, Thomas is hopeful for the future of music therapists; for the apprenticeship scheme that will hopefully boost awareness of the profession, and for the research that continues to bolster
the sector.

“It’s an interesting time to be in the arts therapies, and a great time to be a music therapist.”

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Insight

Now is the time to embrace better ways of working

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By Merryn Dowson, assistant psychologist and part of the team behind rehab goal-setting platform Goal Manager

A stitch in time saves nine. Rome wasn’t built in a day. The best things take time.

We are all too aware that some of the most important parts of our lives have been crafted, carved and developed over months and years. Consider your education, for example: you may well have been to primary school, secondary school and then sixth form college. Perhaps you went on to do an undergraduate degree.

You may even have taken another leap and completed a Master’s degree or a Doctorate. This took years. You learned, revised, sat exams, sat resits, applied for places, got results, got rejected, got accepted, and made it here.

One thing is certain: compared to all of this expertise, someone who completed a two-hour online course on the same topic does not come close. We know that putting time and effort into something gives us better results than if we tried a quick approach.

We do not always lead by this example though. Despite the knowledge that great results are only achieved through hard work and perseverance, sometimes we decide just not to bother. Often, a room in our home might look cluttered, worn down and unloved and it could be made to look incredible.

The walls could be painted, clutter cleared, carpet cleaned, furniture patched up, curtains updated, but it is so much effort. We see the effort it would take and keep living with it. It does the job. It’s fine.

We heard this a lot when we began to develop our software. Goal Manager was designed from within a clinical neuropsychology service with young people with acquired brain injury, and we recognised how goal setting was becoming an intimidating concept within our service and our colleagues across the field.

To combat this, we developed an online goal-setting platform which streamlines the key processes of goal setting into one system and allows members of multi- disciplinary teams (MDTs) to collaborate on goal data remotely.

Crucially, it was designed to fill a hole. The more daunting goal setting became, the more it was shied away from, and the guidelines for goal setting that had emerged from the literature were falling to the wayside.

While we designed our platform to save time on completing all of the gold-standard processes of goal setting compared to doing them manually, we found that people had often not been completing them at all. It was all too complicated.

As a result, we recognise that adopting a software solution like Goal Manager can come with its own problems to solve. It requires relearning a lot of
what we know about a concept like goal setting, understanding properly how these key processes work and how they can be applied clinically to benefit clients.

It is only then that you can start to think of ways to make it more efficient. To help with this, our users are offered bespoke demonstrations, guided MDTs through meetings to help with the clinical application of the data, and training on assessments and goal attainment.

This takes time. Our users are often throwing out their previous guide and writing a new one. When surveyed, however, every single one who responded said that it was worth it.

This brings us back to where we started: the best things take time; Rome was not built in a day; a stitch in time saves nine. By taking time to develop an understanding of goal setting and being able to apply it to a software solution, users experience all of the benefits of best-practice goal setting outlined in the literature both for their clients and for their teams.

Clients are motivated, rehabilitation is meaningful, important areas to address are highlighted, MDTs are focussed, clinical practice is evidenced – the list continues. None of this would have been possible without the initial investment of time.

While simple enough to read, this is no doubt overwhelming to apply to your service or practice and, with this in mind, there are some key points to remember. The most significant is that there is no better time than now.

The world is slowly opening its eyes, sitting up in bed and having a good stretch after the darkness of the Covid-19 lockdown. It is not yet certain if we are going back to snooze or if we are leaping out of bed afresh.

What we do know, however, is that we are heading into a brand new day. Even for those of us who continued in practice throughout the pandemic, services have been slightly paused in one way or another, whether that be refraining from home visits or having fewer people in the office.

We are all very aware that we are heading into the “new normal” rather than our old ways. Use this time to bring new and innovative ways of working into your practice. You might completely change your filing system, consider how you approach your waiting lists, or change how you approach MDT meetings.

Whatever you have been wanting to do for you and your service for so long, now is that time.

Perhaps you decide that you are going to welcome change but not all at once. That works too! For users of Goal Manager, we often suggest that starting with one or two clients might feel more manageable than a whole caseload.

This can help get to grips with the new concepts and ways of working without feeling like everything is completely disrupted. This applies elsewhere too. If you are wary of integrating a system into your whole service, start with one corner of it, evaluate, take what you have learned and then look to apply it more widely.

Finally, remember that all time taken to improve and grow impacts more than just what you set out to do. When people lose weight, they rarely conclude
by saying they just lost weight: they often enthuse about how they feel more energised or move easier or feel more positive or experience less anxiety.

This applies to any time you invest in developing your clinical practice or your service.

While time spent learning how to use Goal Manager and establishing it within a caseload is designed to improve goal setting, that investment also leads to improved assessment processes, more effective meetings, improved digital literacy, increased patient involvement and so much more.

The potential is enormous. To motivate you to start the process, look at what you want to achieve and how that might trigger other improvements.

While the world is still trying to drag its head off the pillow to open up the lockdown curtains, look to invest in addressing those needs you have always been aware of but never felt like you could justify the time.

Walk around your “house” and look into each room: is this the best it can be or could I give it a lick of paint?

Is now the time to bring meaningful solutions into my practice? Maybe grab a tester pot and try a new shade on the walls. Sign up for a free trial. Plan to grow and improve. Start building Rome.

To invest in improving your goal setting, visit www.goalmanager.co.uk to register for a live demonstration, sign up for a free trial or request a bespoke tour through the platform and its features.

 

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