World's largest clinical trial to address disabling cognitive condition affecting one third of stroke survivors
By: Communications
A major new research trial led by academics at the University of East Anglia (UEA) and taking place at eight major stroke centres across England, will test the efficacy of a new therapy for a disabling post-stroke condition that affects around one in three survivors, thanks to a £1.26m grant from the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
A stroke is caused by blood supply being cut off to part of the brain, killing brain cells. This can affect the brain’s ability to interpret information. In some cases, this can make the stroke survivor lose attention to things on one side of their body. This means that even if they have good eyesight, their brain does not process the information it’s getting from the impaired side, resulting in a disabling cognitive condition called ‘spatial inattention’ or ‘spatial neglect’.
There is currently no effective treatment for spatial inattention and people affected by it often have poor recovery and long-term disability. However, in earlier small trials led by academics at UEA, a new therapy called SIGHT (Spatial Inattention Grasping Therapy) showed promise in improving the condition.
Trial lead Dr Stephanie Rossit, from UEA’s School of Psychology, said:
“There are 1.3 million stroke survivors in the UK, with an estimated 390,000 of those suffering from spatial inattention. The condition can be highly persistent, with 40% of stroke survivors continuing to experience symptoms a year post-stroke. Currently there is no effective treatment for spatial inattention. This new trial is helping to fill the gap in the urgent search for successful treatments.
“We’re delighted that the MRC-NIHR have funded this study, which is the largest study of a spatial inattention therapy to take place anywhere in the world.”
SIGHT requires those suffering from spatial neglect to grasp and balance rods with their less affected hand. Because of the condition, the rods tilt during the first attempts, but feeling and seeing the rod tilt improves performance, which in turn increases attention to the impaired side.
The study will also explore why some people benefit more from therapy than others. To help identify who might benefit most, the trial will measure grasping, vision, cognition, stroke severity and brain structure and function.
For the major trial, which will begin in January 2025 and run until February 2028, 206 stroke survivors with spatial inattention will be split into two groups. One group will receive SIGHT and treatment as usual, while the other group will only receive treatment as usual. Neither the participant, nor the site research team, will be told which treatment they are given. To compare the effect of the therapy, the team will assess patients’ ability to attend to objects, and to carry out daily life tasks before the therapy starts, after therapy, and three months after the end of therapy.
According to the World Health Organisation,15 million people have strokes annually, with spatial inattention affecting one in three of these, meaning this low-cost, portable therapy, if found to be effective at improving inattention, could benefit millions of people around the world.
Louise Flanagan, Head of Research at the Stroke Association, said:
“The Stroke Association are delighted that the EME programme has funded this important trial, under the ‘Rehabilitation and Care following stroke’ call. Spatial inattention is a significant cognitive challenge for many stroke survivors and their families and research into effective stroke therapies for cognition has been prioritized by the James Lind Alliance and NHS England. The Stroke Association is excited to support the dissemination and patient and public involvement work of this study.”
The successful application was written with the help of stroke survivors, family/carers, and clinicians. Ann Bamford has first-hand experience of stroke and was actively involved in the application. She will also lead a group of stroke survivors to work with and provide advice to the research team.
Ann said:
“I am looking forward to working as part of the research team, alongside other patients and public contributors from a wide range of backgrounds and experiences, to explore this very important area of stroke rehabilitation which could transform life for people living with spatial inattention following stroke. It is especially rewarding to see that patient, carer and public involvement is a key component of SIGHT.”
The grant will allow the SIGHT trial to be delivered at an unprecedented scale, representing the largest ever trial involving people with post-stroke spatial neglect to date, with recruitment and delivery taking place at eight major stroke centres across England, including the Norfolk and Norwich University Hospital NHS Foundation Trust (NNUHFT).
Kneale Metcalf, Honorary Associate Professor with UEA and Consultant Stroke Physician at the NNUHFT, said:
“As a practicing Stroke Consultant, I see day in and day out the consequences of this hidden stroke impairment (spatial neglect). It is very frustrating for patients and their families. I am delighted the Norfolk and Norwich University Hospital is participating in this trial, hopefully for the future benefit of our patients. Up to now this area has been very poorly understood and studied.”
Further details can be found on the NIHR website.
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