Here’s a small sample of what professionals and consumers learned at this year’s North American Spinal Cord Injury Conference and Disability Expo in Orlando.
By Rob Ingraham and Tom Scott
Experimental Treatments for Spinal Cord Injury: What You Should Know
As the Internet’s explosive growth has expanded access to thousands, if not millions, of information resources, individuals with spinal cord injuries and disorders (SCI/D) are encountering more and more speculative treatment options that have not been subject to rigorous clinical trials or approved by the appropriate regulatory agencies.
Seeking to help attendees distinguish between legitimate clinical trials and the numerous “experimental” treatments, Director of Education at the Miami Project to Cure Paralysis, Maria Amador, BSN, RN, addressed the American Association of Spinal Cord Injury Nurses and presented an overview of some of the current experimental offerings and introduced a new organization-the International Campaign for Cures of spinal cord injury Paralysis (ICCP). ICCP is devoted to informing the public about what to look for when considering participation in a clinical trial and establishing guidelines for the conduct of these trials.
“Experimental treatments are being offered as clinical treatments without testing the safety and efficacy of the treatment in various clinical trials,” Amador said. Examples of such experimental treatments include:
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• Peripheral nerve bridges
• Shark embryo transplants
• Omentum transposition—a surgical treatment that uses the omentum, a large, fatty membrane attached to the stomach and transverse colon which contains factors that promote the development of blood vessels and support nerve tissue
• Tissues and cells from the nasal mucosa, also known as olfactory ensheathing cells
• Embryonic olfactory cells
• Human stem cells
• Umbilical cord blood stem cells
• Bone marrow stem cells
Amado explained that the risk of these unapproved trials, most of which are taking place in foreign countries, include increased and long-lasting pain; further loss of function; increased disability; medical complications or death; loss of health care coverage should complications occur after an unapproved treatment; and exclusion from future SCI/D clinical trials.
To help individuals with SCI/D identify good clinical trials, Amador noted that a reputable clinical trial will have “undergone extensive investigation in animals and will have shown a strong and repeatable effect,” and “carefully designed to compare a group of patients receiving the experimental treatment with others receiving no treatment, or a ‘placebo.’”
Amador explained that, in the absence of a clinical trial in which the effects of the treatment are compared with a control group, “it is almost impossible to determine whether the treatment is really effective.”
She also warned against treatments offered for material gain. “Unfortunately, where patients are desperate for a cure, there is the opportunity for less scrupulous organizations to offer unproven treatments to those who can pay.” Amador explained that patients should never have to pay for any procedure specifically related to a clinical trial program.
The ICCP advises very strongly that candidates “should only participate in properly designed and conducted clinical trials of treatments for which there is compelling evidence of efficacy from animal experiments.”
Amador explained that it takes three clinical trial steps, or phases, to qualify a treatment for human patients:
Phase 1 is designed to learn if the treatment is safe. “A fairly small number of patients, usually between 20 and 80 are given the treatment, initially at a low dose, to see if there are side effects.”
Phase 2 looks for positive treatment effects, comparing the treatment with a control group.
Phase 3 proceeds if a useful effect is seen in Phase 1 and usually includes a larger number of patients in several participating clinics. If the treatment shows a clear, useful effect and no serious side-effects, (usually from two, separate Phase 3 trials), then it will be approved by the national regulatory agencies for clinical use.
For a more complete discussion of all the issues surrounding clinical trials and a checklist of what to ask before joining a trial, ICCP is offering a free, 40-page download, Experimental Treatments for SCI: What you Should Know at www.icord.org/iccp.html.
Low-Cost Assistive Technology Alternatives to Increase the Quality of Life of Persons with SCI/D
Addressing the American Association of Spinal Cord Injury Nurses, Tracie N. Hawkins, OTR/L, an occupational therapist at the Roger C. Peace Rehabilitation Hospital in Greenville, SC, said that most people think of assistive technology (AT) as “high cost, very complex, computer-based options.” But quoting RESNA (Rehabilitation Engineering and Assistive Technology Society of North America), Hawkins reminded attendees that AT is defined as “Any item, piece of equipment or product system, whether acquired commercially, modified or customized, that is used to increase the capabilities of an individual with a disability.”
Hawkins noted that many types of assistive technology are not expensive and AT is “anything that we can come up with to make people’s lives easier.” She said that AT provides increased independence and control to newly injured patients, decreases the burden on caregivers, and increases the feeling of self-worth for individuals with SCI.
One of the most important concerns of people with SCI is having the ability to contact a caregiver in the event of an emergency and relieve the anxiety of being alone. For keeping in touch with caregivers in another room, Hawkins suggested the Sammons Preston E-Z Universal Call device for about $175 or an $80 Personal Pager and noted that a simple baby monitor or a wireless doorbell ringer can also be used.
For adaptive dinner utensils, there are a number of inexpensive items: Restorative Care of America, Inc. (RCAI) offers a wrist orthosis and Sammons Preston offers an $8 Universal Cuff and a variety of $10 Vertical Palm Utensils. For keeping hydrated, Hawkins showed a Sammons Preston “Drink Aid” for about $90 and a backpack type device known as a “Camel Back” from North Coast Medical www.ncmedical.com at between $70 and $90. “Mouth sticks” for operating a computer keyboard or a wall light switch, Sammons Preston offers them for between $40 and $60.
A company called X10.com is a manufacturer and web retailer of a variety of home security and home automation products for controlling individual lighting, appliances, and cameras using existing home wiring. Modules are required for each device to be controlled and run about $10 each. A transmitter costs about $13 and X10.com also offers a $50 “5-in-One Universal Remote “controller or a $20 Palm Pad Remote Control device.
For telephone access, a large-button speaker phone can be bought for about $30 and Ameriphone is offering a hands-free phone, the RC2000, for about $400, plus cost of switches. Hawkins said that Bellsouth/AT&T is offering a leasing program, and suggests calling 1-800-390-7770 for availability in your area.
ETO Engineering offers the “EasyBlue” headset cell phone that employs Bluetooth technology and a large TASH switch to turn the unit on and off, for about $249 and the “VoiceOnly” system that employs a speaker system, requires no buttons, is voice-activated, and is designed for a power wheelchair, a bedside mounting, or in a car for about $299.
For remote control users, Sammons Preston offers a Large Button Universal Remote Control for about $60 and Invoca makes a Voice-Activated Remote Control, also about $60 at Brookstone stores or through www.amazon.com.
The TASH Mini Relax employs a scanning infrared transmitter that controls the TV, VCR, or any other device that operates using infrared. It will store up to six functions, with large graphics and it provides visual and auditory feedback for about $330 and a TASH Mini Relax with X10 for about $375.
Below are additional Web sites that feature numerous assistive technology sources:
“Let’s Talk About Sex”—SCI Sexuality and Relationships
Spinal Cord Injury (SCI) sexuality is a complex topic that can involve many psychological issues. Stanley Ducharme, PhD, at Boston Medical Center who works closely with individuals with SCI, Traumatic Brain Injury (TBI), and other disabilities at the Center’s Institute of Sexual Medicine, tackled this subject during the consumer workshop portion of the 2007 North American Spinal Cord Injury Conference and Disability Expo in Orlando, Florida.
“Traditionally, people with spinal cord injuries and other disabilities were seen as asexual and really no information was received about sexuality. There was poor collaboration between rehabilitation professionals and other health care providers that provided education and services that focused on sexuality. So people like urologists, endocrinologists, and gynecologists really had very little interface with people in rehabilitation,” Ducharme said.
According to Ducharme, there has been a lack of research in the area of sexuality and disability and most of the research done in the past has been “anecdotal and retrospective in nature.”
“[Researchers and health care professionals] have always known that people with spinal cord injury wanted information about sexuality. We knew that it was something that should be addressed in rehab, but we didn’t know how it should be done. There were no treatment protocols or set standards as to how professionals should be addressing this area in the rehabilitation process,” he said. “When I first started working in rehab all we could really provide to people with spinal cord injuries was education and counseling to try to help them adjust. It was sort of a negative approach and we didn’t have any answers for them.”
This changed in the 1970s when Drs. Ted and Sandra Cole at the University of Minnesota introduced the topic to the field of rehabilitation medicine by developing ground-breaking educational workshops called Sexual Attitude Reassessment Programs (SARs). The workshops helped professionals get in touch with their own feelings about sexuality and helped integrate training into the medical school curriculum on issues of sexuality. The involvement of sexual medicine specialists and urologists also played a role in the emergence of sexuality in SCI rehabilitation.
Another major development in the 70s was the introduction of the penile prosthesis which led to the development of many other devices to enhance sexuality for individuals with SCI and other disabilities. Rehab and medical professionals now had more to offer patients and this sparked a change in available services and treatment options and a revolution in SCI sexuality.
“It was really patients with spinal cord injuries that put pressure on the rehab doctors and professionals to talk about sexuality. They began to demand this kind of service and information from their doctors,” Ducharme said.
The next change came in March 1998 when the FDA approved Sildenafil citrate (aka Viagraâ„¢) for use in treating erectile dysfunction. Several years later, spring-boarding on the success of Viagra, pharmaceutical companies began to search for a female equivalent. Although this was unsuccessful it did bring much needed attention to female sexual issues, including those facing women with SCI.
Ducharme also addressed the need for sexual education for individuals after they leave the rehabilitative setting. “Most people, even a year after discharge, have really not mastered sexual adjustment and are not ready to address sexual issues. This is not something that happens over night. It’s a long process of trial and error. This is an important point that needs to be addressed early on during the rehabilitation process,” Ducharme said.
Alcohol Use After Spinal Cord Injury
The rate of alcohol abuse in the Spinal Cord Injury (SCI) population (25%) is approximately twice that of the general population. Statistics show that 46 to 50% of spinal cord injuries due to trauma involve alcohol and that 68% of individuals with SCI have at least one drink as an inpatient. Alcohol and drugs are also a factor in 30% of all pediatric SCIs.
Theresa Duffy, BS, RN, CCM, of Shriners Hospitals for Children in Philadelphia, Pennsylvania gave an overview of the impact alcohol has on the SCI population and strategies to decrease risk of abuse and dependence.
“Most of us know that alcohol use can cause severe health consequences. People with SCI may not be aware of the unique health problems associated with alcohol use, even in small amounts, after SCI,” Duffy said.
A long list of physical implications of alcohol abuse for individuals with SCI includes bladder and kidney damage; dysreflexia; skin breakdown; low bone density; negative interactions with medications; and physical injuries. There are also numerous psychological effects, including severe depression which can lead to suicide— a major cause of death in patients with SCI, especially in the younger population (under 25 years of age). According to the National Epidemiologic Survey on Alcohol and Related Conditions, teens can become alcohol dependent in as few as six months. About 1 in 5 individuals with SCI will experience depression and alcohol abuse can be a catalyst.
In order to help prevent alcohol abuse after SCI, Duffy explained that newly injured individuals should be educated during their initial admission to a rehabilitation hospital. “This is especially important in the case of individuals that were injured due to alcohol consumption . . . Strategies to decrease risk should also be discussed with family and caregivers,” Duffy added.
Creating and providing alternatives to drinking is a good way to prevent alcohol abuse, such as participation in wheelchair sports, SCI support groups, community-based activities, and school clubs. Individuals with SCI should also participate in skill-building activities that teach stress management, assertiveness, problem-solving, decision- making, communication, and methods to resist counterproductive activities.
A useful tool in diagnosing alcohol dependency is the CAGE questionnaire, which consists of four questions:
Scoring: One point for each positive answer.
- Have you ever felt you should Cut down on your drinking?
- Have people Annoyed you by criticizing your drinking?
- Have you ever felt bad or Guilty about your drinking?
- Have you ever had an “Eye opener” first thing in the morning to steady nerves or get rid of a hangover?
Score 1-3 warrants further evaluation.
Score of 1: 80% are alcohol dependent.
Score of 2: 89% are alcohol dependent.
Score of 3: 99% are alcohol dependent.
Score of 4: 100% are alcohol dependent.
Ewing, JS, the CAGE questionnaire, Journal of the American Medical Association, 252(14): 1905-1907, 1984.
If you are an individual with SCI and do not consider yourself at risk for alcohol abuse, but do enjoy a drink now and then, Duffy identifies some strategies to keep in mind while drinking:
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• Determine interactions with medications
• Keep track of the number of drinks
• Know the amount of alcohol in your favorite drinks
• Sip drinks and spread them out
• Make every other drink nonalcoholic
• Be prepared to use catheter more frequently
• Watch for signs of dysreflexia
• Stay alert to prevent accidents or falls
Although alcohol abuse affects many individuals with SCI, it’s never too late to change your habits. By regulating your drinking and adding more positive activities to your daily routine, such as interacting with your family and friends, participating in wheelchair sports, and becoming a part of your community, you can increase your quality of life in a big way.
Rob Ingraham is senior editor. Tom Scott is staff editor.
Very interesting article, especially the section about Alcohol Abuse. Thank you