Patient Manual for the BION ™ stimulation trial for pressure ulcer therapy

1. Preventing Pressure Ulcers Patient Manual for the BION™ stimulation trial for pressure ulcer therapy

2. You have been asked if you wish to be part of a study to evaluate the usefulness of a new pressure ulcer treatment… Unless paralyzed muscles can be exercised, they shrink in size. This can eventually cause pressure sores two ways: first, the thinned can be squished down more easily, blocking blood flow and causing tissue breakdown. Second, the paralyzed buttock muscles cannot contract to shift the weight temporarily from one are to another, causing long periods of time of constant pressure, day after day. Increasing muscle thickness may restrict blood flow decrease under pressure. Muscle contractions may increase blood flow and shift pressure back and forth, avoiding constant pressure for long periods of time. The only way to activate paralyzed muscles is to stimulated them with small electrical pulses. Scientists have now developed a tiny device, called a BionTM, that can be implanted in your muscle to deliver electrical pulses without stimulating your skin. The BionTM is a tiny glass capsule with metal ends. It is about the diameter of a grain of rice but twice as long. If you receive this implant, it will become embedded in your muscle just like other devices, such as pins and screws that physicians often use to make repairs inside the body. The capsule will emit an electrical pulse only when it receives commands and energy by radio waves from a specially designed ring that you place on your lower back when you are ready to exercise the gluteus muscle. A new study I have a pressure ulcer Pressure ulcers are caused by long-time pressure in one area of the body. Pressure prevents blood flow, and compresses the tissue itself. If the pressure squeezes tissue between a bone and a hard or semi-hard surface, pressure sores can appear. Pressure sores are most often seen in individuals who cannot move much, because the pressure is not relieved often enough. Why is the pressure ulcer on my buttock? The buttock is an area of the body under a lot of pressure – literally! non-paralyzed people working at desk jobs try to move around during the day; they shift their weight from one side to the other, they get up, they add a cushion to their chair, etc. If you are sitting or even lying for most of all of the day, the buttock area is ‘squished’ between your body weight and the chair, wheelchair, bed, sofa you are on. Because you buttock muscles (the gluteus and others) cannot exercise, they become thin, making the ‘cushion’ between your hip and pelvic bones and your chair slim. Because you cannot shift your weight during the day, the pressure is not relieved at all from that area, blocking, at least partially, blood flow to the tissue there. This can result in a tissue break down; the pressure ulcer. 1 2

3. The treatment we propose has two phases: a ‘strengthening’ phase and a ‘weight shifting’ phase. During the strengthening phase, we want to make your muscle contract in order to increase the size of it, and promote blood flow in it. During this part of the treatment, because you are recovering from flap surgery, you will spend most of your day lying on your belly. For the strengthening therapy, you place a fabric or rubber-covered ring on your lower back. This ring has a control unit that allows you to turn it on and off. Unless you place the ring over the muscles containing the Bions™, the Bions™ will not receive energy and cannot stimulate your muscle. The radio commands are very specialized and cannot be copied by other types of remote controls, televisions, radios, microwave ovens or electrical scanners (such as those at airports). During the weight shifting phase of the treatment, you will be sitting in your wheelchair and you will place the ring behind your lower back in your wheelchair and use a different stimulation program that will make your buttock muscle contract and relax. The goal of this part of the study is to shift the pressure so that no one part of your buttock is under constant load while you are sitting. The BION is placed in your gluteal muscle during the flap surgery. The area where the BION needs to be implanted (next to the nerve) is exposed during the surgery so it is placed by the surgeon at that time, and tied using biodegradable (‘melting’) suture. Before the BION is sutured in place, it will be tested to ensure that we have achieved the best location for it. After it is sutured in place, the remaining of the flap surgery will proceed as planned. The BION will be turned on shortly after the surgery to ensure that it is positioned correctly and that it works, but therapy will not start until 5 to 7 days after your surgery, to ensure that the area around it heals well. How are BIONs implanted? BIONs image of subject in wheelchair? 3 4

4. The BION is left to heal into the muscle for a few days. You will then receive a “fitting session”. We will measure the ability of the BION to stimulate the gluteal muscle and we will design an exercise/stimulation program just for you. The exercise program is stored in the personal trainer box, which is connected to the ring that you put on your lower back. You must position the ring as your doctor or therapist instructs, then turn it on. The implanted device will begin the exercise automatically. You will be given a schedule telling you for how long to run which program each day. For the conditioning phase, you will exercise your gluteus for 5 hours per day, in a minimum of 3 sessions of maximum 2 hours each. You can decide what works best for your schedule: 2 hours in the morning, 2 hours in the afternoon and 1 hour at night, or 5 sessions of 1 hour each, etc. After starting the program, measure the time you exercise and simply press the stop button when you have achieved the time recommended. It is important that your muscles receive their full treatments to ensure their best recovery. Please try to schedule your “exercises” so that you can complete the whole cycle. Many patients find that exercise can be timed with a favourite TV show. After a few days, the strength of your muscle should increase, just as it would if you did any other kind of exercise. We will decide whether your exercise program should be modified to challenge your muscle a little more and make it stronger. For the weight shifting phase, the BION should be turned on at all times when you are sitting in your wheelchair; if you do not sit for at least 5 hours, you must make up for the missed time by doing some conditioning while lying down. It is crucial to use the BION any time you are sitting in your wheelchair since this is how we are trying to relieve the pressure on your buttock. What happens afterwards? You are an important part of our team! We will work with you to customize your treatment. We need you to help us by telling us: • how you manage to fit the treatment in your daily schedule • whether you are stopping treatments early or skipping treatments • if you have any redness, pain or swelling as treatment progresses 5 6

5. These tests will be repeated throughout the treatment period. Each testing session will probably take one or two hours (MRI sessions can be long), but we will arrange the sessions so that you do not become tired. These tests should not hurt you. They will be explained clearly to you and you will receive a customized schedule of additional tests. Because each person heals differently, the tests will be schedule depending on your healing after the flap surgery. It is important that you make your follow-up visits. Please notify us if the date proves to be impossible and we will reschedule your tests. The strengthening treatment will last as long as you spend a lot of time lying down after your flap surgery. After, once you spend a least 5 hours per day in your chair, you will be in the weight shifting phase of the treatment. The total study lasts ___ weeks. You may wish to discontinue further treatment at the end of the study; the BION will remain inert in your muscle forever. You may, however, choose to continue with the weight shifting phase of the treatment whenever you are sitting in your wheelchair. This may decrease the chance of you getting another pressure ulcer. You should discuss this option with your doctor or therapist. If at any time during or after the treatment period there are any problems caused by the presence of your BION, it can removed in a minor surgical procedure. When the treatment ends… Monitoring your progress At intervals, we will be doing several tests. Before we implant the Bions™, we will use MRI to estimate your gluteal muscle size. We will also use a pressure mapping system to determine where the pressure lies when you are sitting. 7 8

6. Should I take any special precautions? BION therapy is not a replacement to other precautions and treatment your doctor recommends for pressure ulcers. Please do not alter your other treatments, but add BION therapy to your day. The implants themselves should not affect your daily life or the normal use of your wheelchair. Bions™, like pacemakers, contain small amounts of metal and an electronic chip. Please tell your doctors that you have these devices in your shoulder. The devices are safe around microwave ovens and other types of household electronics Neither the Bions™ implants nor your participation in this study should have any affect on the medical and rehabilitation therapy that you will receive to maintain your health. If you have questions about any of the procedures or health concerns, please contact: Dr. Gerald Loeb A.E. Mann Institute for Biomedical Engineering University of Southern California 213-821-1112 gloeb@usc.edu Dr. Hilton Kaplan A.E. Mann Institute for Biomedical Engineering University of Southern California 213-821-0824 hkaplan@usc.edu Precautions Who do I contact if I have questions or concerns? 10 9