GRS Newsletter – July 2022

Join a Clinical Trial - Newcastle Research Institute - Genesis Research Services

This year has so far seen a much welcome boost to the number of studies starting up here at Genesis Research Services, along with significant updates to the team. We are thrilled to have Dr Cillian Suiter join our team of investigators. We have also welcomed a new manager, Dr Julia Kuszewski, and two new coordinators, Natalie and Avril, to the team!

Please note that as a healthcare facility, we continue to implement precautious measures against COVID-19. We ask that all trial participants and visitors to our site wear a mask and practice social distancing whilst inside the building. Masks will continue to be worn by our clinical staff and by all other staff when in communal areas of our building. Masks are provided at reception if required. We hope you stay well.

CURRENT STUDIES

Apply for a clinical trial for chronic back and leg pain. Study site in Newcastle Australia.

New Spinal Cord Stimulator for Chronic Low Back / Leg Pain

This study involves an investigational spinal cord stimulator device with 24/7 remote monitoring and engagement for people living with chronic low back and/or leg pain.

Participants will first trial a temporary device to determine if they are eligible for a permanent implant. Implanted participants will be followed-up for 24-months with site visits and remote management.

View our trials page for more information.

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Neuropathic Low Back Pain: Sciatica / Radiculopathy Trial

Neuropathic low back pain may be the result of compression or impingement of a nerve. It may include sciatica, a type of lumbar radiculopathy, which is nerve pain that starts in the lower back, radiates deep into the buttock, and travels down the leg.

We are looking for people living with neuropathic low back pain to join a clinical trial involving a new treatment.

View our trials page for more information.

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Register for Future Osteoarthritis Knee Pain Studies

Knee osteoarthritis is characterised by bone changes, progressive loss of cartilage, joint space narrowing, and even total joint failure. It causes pain, physical disability, and reduced quality of life. Current treatments include medications, creams, gels, and injections.

We frequently conduct trials involving treatments for osteoarthritis of the knee. Treatments may include oral medications, topical treatments, or injections. To register your interest for future studies, visit our trials page.

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Register for Future Low Back Pain Studies

Low back pain is one of the most common types of pain reported by patients and the leading cause of disability worldwide.

We conduct numerous trials for people living with low back pain. Trials may involve injections or medical devices such as spinal cord stimulators. Medical costs are typically covered (no private health insurance is required). To register your interest for future studies, visit our trials page.

STUDY HIGHLIGHTS

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Subwave Results Presented at INS World Congress

Dr Marc Russo attended the International Neuromodulation Society’s 15th World Congress in Barcelona where he presented promising 6-month data on our investigator-initiated “Subwave” clinical trial.

The trial investigated a new spinal cord stimulation waveform that targets dorsal horn dendrites in the spinal cord without producing paraesthesia (pins-and-needles) to treat chronic neuropathic low back pain.

Read more here.

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Study Recruitment and Enrollment Highlights

Our coordinators are powering through study recruitment and enrollment!

We are currently the second highest recruiter for a study evaluating a new treatment for osteoarthritis of the knee. We were also the first site in NSW to have a patient implanted with a spinal cord stimulator as part of a new study for chronic low back and/or leg pain – this is the second patient implanted in the entire study.

Well done, team!

NEW INVESTIGATOR

Welcome, Dr Cillian Suiter

We are thrilled to have Dr Cillian Suiter join the Genesis investigator team! Dr Suiter is a fully qualified Pain Specialist and Anaesthesiologist from Ireland who recently joined Hunter Pain Specialists. He studied medicine at University College Dublin and completed his specialist anaesthesia training in Ireland. He then undertook two years of pain fellowship training and was awarded the gold medal in the Fellowship of the Faculty of Pain Medicine of Ireland examination.

Dr Suiter believes pain medicine is an exciting area and aspires to be a future leader. He is passionate about research, especially new innovations in pain medicine, neuromodulation, and cancer pain management. He decided to come to Australia to gain further subspecialist experience in advanced neuromodulation techniques and state-of-the-art multidisciplinary care, working alongside Dr Marc Russo and Dr Willem Volschenk.

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TEAM UPDATES

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Welcome, Dr Julia Kuszewski

Introducing our new Research and Business Manager, Dr Julia Kuszewski! Julia brings experience and knowledge in all aspects of clinical trials. She has worked as a Research Officer, a Clinical Trial Coordinator, and has successfully grown an independent clinical research site as a Site Manager.

Julia has a Bachelor of Biomedical Science from Maastricht University, a Master in Cardiovascular Research from VU Amsterdam, and a PhD in Human Physiology from The University of Newcastle. She speaks English, German, Dutch, and a little bit of French.

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Goodbye & Good Luck, Mel

We recently said farewell to our Business Development Manager, Mel Goldman. Mel worked with us for over 9 years and brought so much to the team. With her extensive skillset and go-getter attitude, she improved so many processes and procedures and played a great part in growing Genesis Research Services.

Mel will be dearly missed. We wish her all the best for the future!

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Welcome, Natalie

Welcome to our Research Nurse and Clinical Trial Coordinator, Natalie Sanderson! Natalie joined the Genesis team earlier this year. She is a highly qualified Registered Nurse with a Masters in Advance Practice Nursing. She has extensive experience in NSW hospitals, in dual roles of nursing and trial operations.

Natalie believes medical research is an exciting area of nursing, improving the quality of life of trial participants, and creating future solutions.

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Welcome, Avril

Welcome to our newest Clinical Trial Coordinator, Avril O’Brien! Avril is an experienced Quality Associate professional with over 15 years of experience in the TGA, FDA, EU & IMB regulated industry. She has an Honours in Applied Science – Bioscience from the Cork Institute of Technology in Ireland and is fluent in sign language.

Avril sought a coordinator role to contribute to research and bring new treatments one step closer to reaching patients worldwide.

OTHER NEWS

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SCRS Site Solutions Summit 2022

Julia, Natalie, and Avril recently attended the Society of Clinical Research Sites (SCRS) Australia-New Zealand Site Solutions Summit in Melbourne (12 – 13 July).

The girls thoroughly enjoyed the conference and found the two days of sessions to be full of valuable information. They came back feeling inspired and shared what they learned about the changing world of clinical trials with the rest of the team.

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Neuromodulation World Congress 2022

Dr Marc Russo attended the International Neuromodulation Society’s 15th World Congress in Barcelona (21 – 26 May).

Along with the 6-month results of the Subwave clinical trial, he gave talks on the aetiology (causes) of chronic mechanical low back pain, and on conflicts of interest within the neuromodulation industry.

In an interview with touchNEUROLOGY, Dr Russo discusses the highlights of the 2022 INS World Congress.

Read the interview here.

PUBLICATIONS

Ambroxol for Neuropathic Pain

Dr Russo and co-authors just published a review article on “Ambroxol for neuropathic pain” in the leading journal for pain medicine and research – PAIN!

Ambroxol is an old drug used to treat respiratory tract conditions and sore throat. Interestingly, recent evidence shows that it can even treat neuropathic pain symptoms due to its local anaesthetic, anti-inflammatory, antioxidant, and neuro-protective actions. Benefits have been shown in animal models and patients with various chronic neuropathic pain conditions/symptoms, including trigeminal neuralgia, complex regional pain syndrome (CRPS), fibromyalgia, and more.

The authors hope to see more research that might lead to the development of an optimized version of ambroxol for the treatment of neuropathic pain.

Read more here.

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Restorative Neurostimulation - 2-Year Clinical Trial Results

The long-term results of the ReActiv8-B clinical trial have been published. Dr Russo and Dr Volschenk are investigators on the trial that is ongoing here at Genesis Research Services.

The trial is evaluating the effectiveness of an implanted neurostimulator in patients with disabling mechanical chronic low back pain that is associated with weakness of the multifidus muscle. The device activates the multifidus muscle, one of the major stabilisers of the lower spine, with the aim to restore muscle control and stability of the spine and therefore improve pain symptoms.

Read the full article here.

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Results of Ultra-Low Frequency Neuromodulation for Chronic Pain

Spinal cord stimulation using ultra-low frequency current is a newly developed technology that aims to reduce chronic pain.

We conducted a clinical trial of this investigational therapy for patients with chronic leg and back pain and the results were published in the prestigious scientific journal, Science Translational Medicine.

Read the article abstract here.

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History of Radiofrequency Neurotomy

Dr Russo wrote a review paper on the fascinating history of the development of radiofrequency neurotomy (RFN).

RFN is a procedure performed by pain physicians to treat chronic back pain coming from the spinal joints (e.g. the facet joints or sacroiliac joints). Electrodes are inserted onto the spinal nerves to create heat lesions on the nerves to block the pain signals coming from the joints.

Read the full article here.

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Neuromodulation Feature Article

Dr Russo wrote a feature article for NeuroNews – an international neurovascular & neuromodulation newspaper.

In the article, Dr Russo discusses the evolving landscape of neuromodulation, including spinal cord stimulation and deep brain stimulation, and what the future may hold.

Read the article here.

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