Rare disease concept
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Autoimmune encephalitis is a rare condition affecting 1 in 100,000 people per year in the UK according to the Encephalitis Society. Autoimmune encephalitis is a swelling in the brain caused by the immune system attacking the body in error. It can cause people to become confused, and drowsy, exhibit changes in behaviour, and have seizures. Some patients recover completely, but in others, it can cause death or severe disability.
Even though there is a range of treatment options available to tackle both the causes and symptoms of encephalitis, there isn’t a specific targeted treatment. Currently, the disease is treated with steroids but if the patients don’t
improve, clinicians often give intravenous immunoglobulin (IVIG). IVIG is expensive and can sometimes cause serious side effects. Some doctors also think that if IVIG is used from the start of treatment, patients may recover more quickly and have fewer side effects from the illness.
The Enceph-IG study is hoping to help improve treatment options for patients diagnosed with autoimmune encephalitis. The study looks at whether early treatment with IVIG improves outcomes for patients.
How is it going?
Supporting patients and their families is really at the heart of this study so much so that the original idea came from patients and their families. The research team is led by Professor Tom Solomon, from the University of Liverpool and includes many of the UK’s leading encephalitis and IVIG experts, as well as the Encephalitis Society. The team has worked hard to ensure that the study addresses the needs of the patients and that it addresses the key question of how can we improve treatment for autoimmune encephalitis.
Enceph-IG is an individually randomized controlled trial of 356 adults. All patients will receive steroids and then half will receive IVIG and the other half will receive a placebo. The study will be carried out at about 50 hospitals in the UK. Over the last year, we have opened the study in six sites and recruited nine participants, but things haven’t been easy.
Like so much other research, COVID-19 has impacted our study as well. The research team has worked hard with sites to make sure that the study is as simple as possible to set up and run. We also want to make sure there are plenty of opportunities for learning. In the past, we have helped support clinical staff to attend the annual Encephalitis Society Conference. The study is also part of the NIHR Associate PI scheme. The Associate PI scheme gives non-research-based healthcare staff an opportunity to get involved in a large multicenter trial and helps provide a bit more support to research staff.
Can you help?
The condition is rare but has a severe impact on those affected. The research team is seeking more hospitals to join the study.
If you would like to know more about the study or register as a potential site, please contact email@example.com or visit Enceph-IG – Centre for Trials Research – Cardiff University. You can also follow the trial on Twitter @EncephIG