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Clinical study investigates new SCI therapy

ExaStim neuromodulation system from ANEUVO evaluated through trial

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A clinical study is underway to investigate the feasibility and potential of a new neuromodulation system for people with spinal cord injury (SCI). 

The ASPIRE™ (Assessing non-invasive spinal Stimulation and PT/OT for motor Improvement Response with ExaStim) study will evaluate the safety and effectiveness of the ExaStim device in combination with traditional rehabilitation therapy as an adjunct therapy for people with upper extremity paralysis due to SCI. 

ExaStim therapy, created by ANEUVO, delivers stimulation to the spinal cord to modulate neural networks, which enables improvement in motor function. 

Transcutaneous Spinal Stimulation (TSS) is an emerging neuromodulation therapy with the potential to help individuals living with spinal cord injury improve motor function.

Research and previous trials indicate that non-invasive spinal stimulation may help individuals with spinal cord injuries regain lost motor function and improve functional independence.

“Rehabilitation after SCI is complicated and inefficient. Recovery of function is slow and secondary complications can limit progress,” said Dr Rebecca Martin, manager of clinical research and education at the International Center for Spinal Cord Injury (ICSCI) at Kennedy Krieger Institute and an assistant professor at The Johns Hopkins University School of Medicine.

“TSS via ExaStim has the potential to augment existing therapies, helping patients to restore function and mobility. 

“ExaStim offers a unique multi-electrode array, which allows us to target and control stimulation levels, unlike any device currently on the market. We hope to demonstrate that this novel delivery of TSS will optimise our therapies and yield better outcomes.”

The ASPIRE study is a randomised, prospective, multi-centre clinical study designed to demonstrate the safety and efficacy of the ExaStim TSS system using non-invasive spinal cord stimulation to improve/regain the motor function of individuals with SCI. 

A maximum of 140 patients will be enrolled at up to 14 sites across the United States. 

“The ExaStim TSS system with a flexible multi-electrode array represents an important advancement in non-invasive spinal cord neuromodulation therapy,” said Dr Yi-Kai Lo, CEO at ANEUVO. 

“We are excited to lead the effort through the ASPIRE study to bring this novel device to market, offering physicians and clinicians a new technology to treat patients suffering from spinal cord injury.”

The ExaStim, a non-invasive non-surgical investigational device, has received FDA Breakthrough Device Designation status for the indication of treating paralysis due to spinal cord injury. 

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