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Spinal

Reeve Foundation and SII collaborate to increase spinal cord injury support

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A new Transatlantic alliance has been formed to expand support further for the spinal cord injury community. 

The Christopher & Dana Reeve Foundation has collaborated with Spinal Injuries Ireland (SII) to foster sharing of best practices, expand services and educational content, and enable joint fundraising opportunities in the US and Ireland.

This Reeve-SII collaboration follows an alliance with the International Spinal Research Trust (ISRT), announced earlier this year, as a joint strategic approach to research with a focus on accelerating the progress of therapies and their delivery to the millions of people around the world living with the life-altering effects of paralysis.

As the only support and service agency for those who sustain a spinal cord injury in Ireland, SII provides support for injured people and their families and friends at every stage, with counselling, community outreach, peer mentoring and activity programs. 

Their mission and work mirrors many aspects of the Reeve Foundation’s National Paralysis Resource Center (PRC), which offers comprehensive information, resources, and referral services for the community to achieve a better quality of life.

“The mission of our PRC is to foster involvement in the community, promote health and improve quality of life,” said Maggie Goldberg, President and COO of the Reeve Foundation. 

“Our new alliance with SII will help our organisations cultivate and grow community connections, while learning from each other about the best ways to care for and promote the independence of people living with paralysis, a spinal cord injury, or mobility impairment.”

“Spinal Injuries Ireland is delighted to partner with the Christopher & Dana Reeve Foundation to advance the mission of providing the best care post-injury in the community for people who have sustained a life changing injury,” says Fiona Bolger, CEO of Spinal Injuries Ireland.

“To date, both organisations have shared best practice in a number of services and in addition our collaboration will allow SII to participate and fund future research projects with Reeve and other partners to accelerate research in to therapies and a cure for spinal cord injury.”

Spinal

Revolutionary spinal cord therapy moves closer to reality

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Health tech business ONWARD has secured its third Breakthrough Device Designation status as it continues towards its goal of commercialising its technology which could allow paralysed patients to walk again. 

The venture secured Breakthrough Device Designation for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury.

It is the third such status awarded to ONWARD from the US Food and Drug Administration (FDA), following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility.

ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch. 

A study demonstrated the ability of this technology to enable long-paralysed people to stand and walk again with little or no assistance and a  further recently-published paper showed the potential for this same therapy to normalise blood pressure in people with spinal cord injury.

ONWARD has previously spoken to NR Times about its hope that ARC-IM would be commercially available in 2024. 

“Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” says Dave Marver, chief executive officer of ONWARD. 

“We are excited about this award and thankful to the FDA for recognising the potential of our technology to improve the quality of life for those with spinal cord injury.”

The FDA endorsement comes as the latest breakthrough for ONWARD, following the backing of $32million earlier this year through a fundraising round to help it continue with its journey. 

Previously, Dave Marver told NR Times about how its ARC EX device is expected to be commercially available in late 2023, with its Up-LIFT trial underway in the UK – at the Queen Elizabeth University Hospital in Glasgow – United States, Canada and the Netherlands.

The trial began in January with plans to enrol 65 people at up to 15 centres worldwide. 

An external, non-invasive platform, the ARC EX is set to deliver movement and strength in the hands and upper body of people with spinal cord injury, compared to rehabilitation training alone.

And in one of the most keenly-awaited health tech breakthroughs of recent years, its ARC IM technology is set to go into trials mid next year, with its commercial launch anticipated in 2024.

Both platforms are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement, independence, and health in people with spinal cord injury, ultimately improving their quality of life. 

Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as spinal cord injury. 

As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA’s experts throughout the premarket review phase as the technology moves toward eventual commercialisation.

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Research

New technique brings lasting pain relief for rotator cuff disease

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People living with spinal cord injury can experience lasting pain relief through the injection of micro-fragmented adipose tissue (MFAT) for rotator cuff disease, new research has revealed. 

A team of specialists in regenerative rehabilitation have shown through a pilot study that MFAT can deliver benefits to wheelchair users who experience shoulder problems. 

In the study, nearly 80 per cent of participants saw a meaningful decrease in pain symptoms through an ultrasound-guided injection of MFAT, and all but one reported some improvement in pain and function. 

Scores also declined steadily over the first three months for all metrics, and over the entire year for the BPI-17 pain metric, suggesting that this intervention has long-lasting effects.

“These results show that the minimally invasive injection of micro-fragmented adipose tissue is a safe and efficacious option for wheelchair users with shoulder pain caused by rotator cuff disease,” says Dr Gerard Malanga, author of the study and visiting scientist at Kessler Foundation. 

Shoulder pain is a common occurrence among wheelchair users with spinal cord injury because they rely solely on their upper limbs to perform everyday tasks. 

Often, pain is caused by soft-tissue injuries such as damage to rotator cuff tendons. Many non-surgical therapies for shoulder pain exist, including pain medication, physical therapy, and equipment modifications, but these have shown limited efficacy. 

Persistent shoulder pain can significantly lessen quality of life, and if conservative therapies fail, shoulder surgery is frequently the only option, which comes with its own set of risks and potential setbacks.

Through the single-group pilot study, researchers explored the efficacy of a minimally invasive biological intervention involving MFAT, which has a potential source of bioactive and regenerative components for orthopaedic conditions and may provide cushioning that can improve function and alleviate pain caused by rotator cuff injuries.

Ten wheelchair users with chronic spinal cord injury who had moderate to severe shoulder pain for more than six months caused by refractory rotator cuff disease participated in the study. 

All received an injection of MFAT and were evaluated at six and 12 months after treatment. 

Evaluation metrics included the 11-point Numerical Rating Scale, the Wheelchair User’s Shoulder Pain Index, Brief Pain Inventory pain interference items (BPI-17), Patient Global Impression of Change, ultrasound and physical examinations, and adverse events.

“Based on the success of our study, a randomised controlled study with a larger number of subjects has been initiated in this patient population through funding from the New Jersey Commission for Spinal Cord Research,” says Dr Malanga. 

“We feel there is great potential for this therapy to help people with shoulder pain manage their symptoms and improve their quality of life.”

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Spinal

Exoskeleton ‘can improve bowel function’ in SCI patients

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Exoskeletons could help people with spinal cord injury improve their bowel function, new research has revealed. 

Physical intervention plans which included exoskeleton-assisted walking were shown to help people with SCI evacuate more efficiently and improved the consistency of their stool.

Rehabilitation professionals have traditionally managed bowel dysfunction using approaches that target the gastrointestinal system or require manual intervention, but some newer research suggests that physical activity and upright posture may enhance bowel motility. 

However, few studies have explored the possibility that exoskeletal-assisted walking – in which a person with spinal cord injury wears a robotic suit, enabling them to stand and walk – may be an effective addition to existing intervention plans.

“We saw a notable reduction in bowel evacuation time, with 24 per cent of participants reporting an improved experience,” says Dr Gail Forrest, co-author and associate director of the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation. 

“We also noted that participants’ stools trended toward better consistency, supporting our hypothesis that this intervention may improve several measures of bowel function.”

“Our results support the idea that walking, and not just standing, may have a beneficial effect on bowel function,” said Dr Peter Gorman, co-author and chief of the Division of Rehabilitation Medicine at the University of Maryland Rehabilitation and Orthopaedic Institute. 

“Our goal is to improve the quality of life of those with chronic spinal cord injury, and these encouraging results will help inform future studies on the emerging field of mobility intervention.”

Bowel dysfunction is a common experience after spinal cord injury, and can lead to chronic constipation and incontinence, causing discomfort and frustration. 

In one survey, more than a third of men with spinal cord injury reported that bowel and bladder dysfunction had the most significant effect on their lives post-injury.

In this study, the research team investigated whether exoskeletal-assisted walking improved bowel function in people with chronic spinal cord injury. 

They performed a three-centre, randomised, controlled, crossover clinical trial in which 50 participants completed 36 sessions of exoskeletal-assisted walking. 

The researchers evaluated bowel function as a secondary outcome in 49 participants. Bowel function was measured via a ten question bowel function survey, the Bristol Stool Form Scale, and the Spinal Cord Injury Quality of Life Bowel Management Difficulties instrument.

Results showed that the exoskeletal-assisted walking program provided some improvement in bowel function when compared to a control group.

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