Spinal cord injury is a life-changing condition that creates a need for hands-on help from others for important daily tasks. However, obtaining reliable, high-quality personal care assistance services is often challenging due to the high turnover rates among paid caregivers and insufficient knowledge among home health care workers about the unique needs of individuals living with spinal cord injury.

In response to these challenges, the web-based course, “Understanding Spinal Cord Injury,” was developed as a basic resource to help prepare PCAs for their integral role in the daily lives of people with spinal cord injury. The course’s core modules describe the types of spinal cord injury, common physical needs, personal and social challenges, and potential secondary complications, as well as common misunderstandings about the condition. Four modules address special topics, including building positive assistant-client relationships, managing blood pressure, understanding assistive technology and medical equipment, and transferring clients safely to and from their wheelchairs.

“For people with spinal cord injuries, routine personal care assistance is vital to preventing medical complications and facilitating their involvement at home, work, and school,” said Cheryl Vines, Director of Research and Education at PVA. “However, obtaining reliable, high-quality services is often challenging due to the high turnover rates among paid caregivers and insufficient knowledge among home health care workers about the unique needs of individuals living with spinal cord injuries.” Collaboration was fundamental to the course’s development, according to Dr. Zanca, the project’s director. Guided by a steering committee of people with real-world experience with spinal cord injury—including PCAs, home health care agency leaders, trainers, family members, and rehabilitation clinicians—the modules were developed by Kessler Foundation in collaboration with Shepherd Center. The National Institute on Disability, Independent Living, and Rehabilitation Research NIDILRR) and the Paralyzed Veterans of America (PVA) Education Foundation provided funding.

“Focus groups and interviews were conducted with people with spinal cord injury, family caregivers, clinicians, and experienced PCAs,” Dr. Zanca explained, “to ensure that the modules reflect the priorities of individuals with spinal cord injury as well as the educational needs of assistants.”

Recognizing its focus on client-centered care for spinal cord injury, the North American Spinal Cord Injury Consortium (NASCIC) has endorsed the new course. “We at NASCIC firmly believe in the principle of people with lived experience of spinal cord injury working in partnership with their caregivers, clinicians, and researchers,” said Barry Munro, treasurer of NASCIC. “As a person with tetraplegia who is dependent on attendant care, I feel all caregivers for people with spinal cord injury should take this course,” advised Munro. “I only wish such a valuable resource had been available years ago.”

The course was pilot tested by personal care assistants without prior experience with spinal cord injury care. “Their feedback was positive,” Dr. Zanca  said, “indicating that they gained practical information by completing the course and felt prepared to work effectively with clients with spinal cord injury.”

“Understanding Spinal Cord Injury: A Course for Personal Assistants,” is a significant step towards ensuring the quality of personal care assistance services provided to individuals living with spinal cord injury,” Dr. Zanca emphasized. “Now we are working with our partners to disseminate this resource to the wider community of individuals, families, and professionals who are invested in improving quality of life after spinal cord injury.”

Dr. Zanca’s presentation will also be offered at the annual meetings of the Academy of Spinal Cord Injury Professionals in San Diego, CA (Sept. 3-6), and the American Congress of Rehabilitation Medicine in Atlanta, GA (Oct. 28-Nov 1).

This initiative was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR Grant #90IF0115) and the Paralyzed Veterans of America Education Foundation (Grant #862).

IMAGE: A WOMAN IS SITTING IN A WHEELCHAIR NEXT TO HER MALE PERSONAL CARE ASSISTANT AT AN OUTSIDE TABLE SURROUNDED BY GREENERY. BOTH ARE SMILING BROADLY. view more 

CREDIT: KESSLER FOUNDATION

The research, published in British Journal of Clinical Pharmacology, found that the KCL-286 drug – which works by activating retinoic acid receptor beta (RARb) in the spine to promote recovery – was well tolerated by participants in a Phase 1 clinical trial, with no severe side effects. Researchers are now seeking funding for a Phase 2a trial studying the safety and tolerability of the drug in those with SCI.

Global prevalence of SCI is estimated to be between 0.7 and 1.2 million cases per year, with falls and road accidents being the major causes. Despite incurring a cost of $4 billion per year in direct healthcare and indirect costs (i.e. inability to work and social care) in the US alone, there are no licensed drugs that can tackle the intrinsic failure of the adult central nervous system to regenerate, and thus remains a largely unmet clinical need.

Previous research by various groups has shown that nerve growth can be stimulated by activating the RARb2 receptor, but no drug suitable for humans has been developed. KCL-286, an RARb2 agonist¹, was developed by Professor Corcoran and team and used in a first in man study to test its safety in humans.

109 healthy males were divided into one of two trial groups; single ascending dose (SAD) adaptive design with a food interaction (FI) arm, and multiple ascending dose (MAD) arm. Participants in each arm were further divided into different dose treatments.

SAD studies are designed to establish the safe dosage range of a medicine by providing participants with small doses before gradually increasing the dose provided. Researchers look for any side effects, and measure how the medicine is processed within the body. MAD studies explore how the body interacts with repeated administration of the drug, and investigate the potential for a drug to accumulate within the body.

Researchers found that participants were able to safely take 100mg doses of KCL-286, with no severe adverse events.

Professor Jonathan Corcoran, Professor of Neuroscience and Director of the Neuroscience Drug Discovery Unit, at King’s IoPPN and the study’s senior author said, “This represents an important first step in demonstrating the viability of KCL-286 in treating spinal cord injuries. This first-in-human study has shown that a 100mg dose delivered via a pill can be safely taken by humans. Furthermore, we have also shown evidence that it engages with the correct receptor.

“Our focus can hopefully now turn to researching the effects of this intervention in people with spinal cord injuries.”

Dr. Bia Goncalves, a senior scientist and project manager of the study, and the study’s first author from King’s IoPPN said, “Spinal Cord Injuries are a life changing condition that can have a huge impact on a person’s ability to carry out the most basic of tasks, and the knock-on effects on their physical and mental health are significant.

“The outcomes of this study demonstrate the potential for therapeutic interventions for SCI, and I am hopeful for what our future research will find.”

This work was possible thanks to funding from the Medical Research Council.