Site-Specific Study

Assessment of the Efficacy of Venlafaxine HCI as a Preventative Therapy for Depression and Pain Following New Spinal Cord Injury
                                
In our major site-specific project, we are studying the important issue of preventing depression in people with new onset spinal cord injury (SCI). Despite widespread use of antidepressants, their effectiveness in treating people with SCI has not been studied specifically. Since venlafaxine XR (Effexor XR®) has demonstrated effectiveness in treating both depression and pain, we are examining the effect of this particular antidepressant on the experience of depression and pain in people with acute SCI.

Many people newly injured with SCI report having sleep or appetite changes, poor energy, low mood, and loss of interest. Such symptoms of depression may result, in part, from stress-related changes in brain chemistry. Antidepressant medications, such as Effexor XR®, are designed to rebalance brain chemistry. Participants in this study will be randomly placed in two study groups, with only those in one group receiving the study drug. In order to make comparisons and determine the effectiveness of the study drug, all participants will report, for up to one year, on symptoms of depression, mood, and pain, as well as other important factors, such as stress, anxiety, health, community participation, and quality of life.

Multi-Center Studies

Measuring Quality of Life in Spinal Cord Injury: The Next Generation of Instruments

Quality of Life (QOL) is a concept about a person’s well-being and ability to enjoy life activities. QOL can be affected by one’s health, as well as other important factors, such as personal and community support. Many existing QOL measurement tools do not fully capture the range of experiences one might have when living with SCI. For this study, led by Northern New Jersey SCI System, focus groups that include people with SCI and professionals who work with them are helping to create survey questions for a new QOL instrument. The end result will be a QOL measurement tool specifically designed for people with SCI.

Community Participation Measure for People with Spinal Cord Injury

Community participation is the extent to which a person is an active member of society, taking part in various aspects of family and community life. Many current surveys of community participation that are used in assessing people with disabilities measure only physical abilities and limitations, not the feelings and opinions of the survey respondents. This study, led by Rocky Mountain Model SCI System, is testing a new community participation survey developed specifically for people with SCI. The new survey includes questions aimed at collecting information about feelings and opinions connected with the important realm of community participation.

Motor Recovery Index – A Validation of an Outcome Measure in Incomplete SCI

This research project is led by the Model SCI Care System of University of Alabama at Birmingham (UAB). The goal of this study is to validate the UAB Motor Recovery Scale, which is used to evaluate leg movement after an SCI. This scale tests different muscles at different times after injury. SCI physicians lack an accurate, time-sensitive tool to measure motor recovery. This scale shows promise in this respect, and will be especially important for future studies involving the evaluation of the effectiveness of treatments for SCI recovery.

Development and Validation of the Thoracic-Lumbar Control Scale to Measure Strength and Coordination of Trunk Muscles

This project seeks to create an accurate, reliable tool for assessing thoracic (trunk) muscle activity and function after an SCI. While medical teams have effective ways of evaluating arm and leg strength and function, lacking in the field is a measure for judging the condition of the thoracic spine. The thoracic spinal cord affects nerves and muscles in the trunk of the body, and is crucial in achieving and maintaining balance and stability. The Texas Model Spinal Cord Injury System leads this research study.

Controlled Trial of Venlafaxine XR for Depression after SCI

The Northwest Region SCI System is coordinating a research project with U-M that is designed to improve treatment of depression among people who have had an SCI for over one year. People living with SCI have rates of depression estimated at two to six times higher than the general population. So, Major Depressive Disorder is one of the most common complications related to having SCI. Poorer health, higher rates of suicide, and other medical complications are linked to having both conditions. Researchers hypothesize that due to severe stresses, changes in life roles, physical impairments, and other factors, people with SCI may respond differently to the usual treatments for depression.

The antidepressant venlafaxine XR (Effexor XR®) will be prescribed to determine how this treatment method works for people with SCI. One of the two study groups will be treated with an antidepressant for three months. All participants will be asked about their levels of depression, pain, community participation and other important factors.

For additional information about any of these studies, please contact the U-M Model Spinal Cord Injury Care System at 734-763-0971 or e-mail us at spinalcordinjury@umich.edu.

Other SCI Studies

Coloplast Catheter Study

Coloplast, a medical products company, is working with U-M Health System and other hospitals to test the advantages of using a new type of urinary catheter. Patients on the acute U-M spinal cord injury unit will use a catheter that features a hydrophilic, or “water loving” coating. This study will determine if people using these coated catheters have less urinary tract infections compared to those using uncoated catheters.

Functional Electrical Stimulation Study

FES, or Functional Electrical Stimulation, is a method of rehabilitation using low level electrical currents to improve the function of paralyzed muscles. A small device similar to a pacemaker and tiny electrodes are surgically implanted.  The implanted device sends mild electrical currents to the electrodes, causing the muscle to contract.

FES may help people with SCI and other conditions to exercise, transfer and stand.  And, FES may improve the overall health by reducing secondary health problems, such as pressure sores and spasticity. In addition, FES can improve overall health by:

• Exercising muscles in the lower extremities
• Increasing cardiovascular fitness
• Reducing osteoporosis

Learn more about FES.

Diaphragm Pacing Stimulation Study

If damage to the spinal cord occurs in the neck, or cervical area of the spine, breathing muscles are affected such that people with this type of injury must use a ventilator (artificial breathing device). For these individuals, Dr. Raymond P. Onders and colleagues from University Hospitals of Cleveland, OH created Diaphragm Pacing Stimulation, or DPS. DPS involves surgically implanting a device similar to a pacemaker as well as electrodes into the chest. The DPS stimulates the phrenic nerve, causing the diaphragm to contract and air to enter the lungs. DPS enables people with SCI or ALS (Lou Gehrig’s disease) to breathe normally on their own.

Dr. Onders implanted a DPS for actor Christopher Reeve. As a result, Mr. Reeve was able to breathe more easily and gain independence from a ventilator. Dr. Anthony Chiodo and a physician from U-M Department of Surgery will be collaborating with Dr. Onders in order to bring this exciting project to U-M Health System.

Quality of Life for SCI Clinical Trials:  Development of the SCI-QOL

Quality of Life (QOL) refers to a person’s well-being and ability to enjoy life activities. Although QOL instruments have been created specifically for people with cancer, AIDS, and other conditions, such a tool does not exist for people living with SCI. Led by Kessler Medical Rehabilitation Research and Education Center, the goal of this project is to design a health-related QOL instrument for people with SCI. Focus groups, made up of people with SCI, will assist in generating content for this tool, which will be used eventually in clinical trial research.

Psychological and Physiological Aspects of Menopause in Women with Spinal Cord Injury

Little is known about menopause for women with SCI and how having a disability alters this life experience. The Menopause and SCI project examines the emotional, psychological, and physical changes that midlife and menopause can bring. Participants are surveyed about their levels of stress, depression, physical symptoms, and life events over the course of three years. This research will help determine how gender, SCI, and other factors affect the midlife years.

Menopause in Women with Spinal Cord Injury: a Pilot Study of Elevated Health Risks

This related study, funded by the National Institutes of Health is investigating physical changes during menopause, specifically related to bone loss and risks for heart disease and diabetes among women with SCI. Able-bodied women and men with SCI serve as control groups for this study. To learn more about this research project, please e-mail menopausesci@med.umich.edu.

Self-Management of Spinal Cord Injury and Disease

People with SCI are at risk of developing many possible health conditions related to their disability. Education is not enough to enable a person with SCI to follow a regimen that will help prevent complications including pressure sores, obesity, diabetes, and depression. The goal of this study is to develop a health management program that will prevent secondary conditions and improve health and quality of life for people with SCI. Two training packages will be developed - one for individuals with SCI and one for health care providers. By educating both groups in the expectations and skills associated with self-management, this project aims to facilitate better collaboration.   

Pathways to Depression: An Examination of Vulnerability and Stress in Adults with Spinal Cord Injury

Depression after spinal cord injury (SCI) is a common complication. The condition occurs at higher rates among people with SCI than those without. Depression can limit independence, increase the risk of suicide and lead to poorer health overall. This study will research key factors that may cause some people to be more vulnerable to depression, both psychologically and physiologically, after an SCI. Such vulnerability factors (exposure to childhood adversity, one’s psychological background, substance abuse, genetic predisposition, and gender) may sensitize individuals to stressful events, increasing their risk of depression in later life.  

We will attempt to broaden our insight into why some individuals are able to thrive after injury and others not. Also, the project seeks to understand why injury factors do not necessarily predict who will become depressed. A better understanding of the influences that incline some individuals towards depression can enable health providers to intervene and reduce the occurrence of depression and related difficulties.