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Research and Clinical Trials
Trends in Multiple Sclerosis Research
The Johns Hopkins Multiple Sclerosis Center is involved in many facets of MS-related research. Financial support to conduct many of our investigations has come from multiple sources over the years, including the National Institutes of Health and the National Multiple Sclerosis Society.
Multiple sclerosis related research is active worldwide because the underlying cause of this devastating disease still remains unknown. Existing treatment strategies are only partially effective, leaving a desire for new therapies.
Our researchers have a long-standing interest in studying how the nervous system and the immune system interact, a process that goes markedly awry in multiple sclerosis. Determining, for example, how white blood cells manage to get into and out of the brain may eventually lead to new treatments that inhibit this process.
This is important because an influx of these white blood cells into the brain is believed to start the process which leads to MS. Different types of white blood cells also “talk” to each other by releasing particular chemical signals. How these signals are controlled is very different inside the brain compared to other organs. By understanding how the brain influences this process under normal circumstances, we hope to gain further insight into what goes wrong to allow these signals to trigger MS.
There has been a lot of recent research focused on actual injury to the nerve cells in MS lesions, not just their myelin coverings which have traditionally been thought to be the primary target of the immune system. An important aspect of our research focuses on improving our understanding of how these nerve cells are injured and how this injury might be prevented or reversed. This approach may eventually lead to new MS therapies.
For more information, contact the Johns Hopkins Multiple Sclerosis Center at 410-614-1522.
Current Clinical Trials
Functional Electronic Stimulation for Individuals with Secondary Progressive Multiple Sclerosis
Clinical Trials.gov Identifier NCT01647321
Principal Investigator: Scott Newsome, D. O.
Dr. Newsome is currently recruiting subjects for a research study to determine if functional electrical stimulation (FES) cycling improves walking in subjects with Secondary Progressive Multiple Sclerosis (SPMS). SPMS is a subtype of multiple sclerosis (MS) for which there are no existing therapies that can prevent or substantially slow down progression of disability. Virtually every person with SPMS will develop difficulty walking leading to use of canes, walkers, and eventually wheelchairs. FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. It has been used most in rehabilitation of patients with traumatic spinal cord injuries. Over the recent years FES cycling has become an increasingly important modality in rehabilitation of patients with paralysis. It has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory environment in the brain and spinal cord. To investigate whether FES improves walking in patients with SPMS, we are conducting a pilot study in which 20 SPMS patients (separated into two groups) will receive 1 hour of either cycling with electrical stimulation or without electrical stimulation 3 times a week for 12 weeks at the International Neurorehabilitation Institute, in Lutherville. Only individuals with a diagnosis of SPMS aged 18-68 years may join. Our main outcome measure in this study will be the timed 25-foot walk test. This test evaluates how many seconds it takes individuals to walk 25 feet. We are also assessing whether cycling with FES will result in a change in other MS disability measures including spasticity, strength, sensation, dexterity, endurance, fatigue, depression, and overall quality of life. This study may help us determine if there is a benefit from FES and what may be the underlying mechanism(s) for this benefit. This in turn will help us design future clinical trials using FES. Since no therapeutic intervention has been shown to modulate disability in patients with SPMS, if FES improves function in these patients, then it warrants further investigation in a larger study. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. This treatment may help ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost.
Dimethyl Fumarate (DMF) Observational Study (ESTEEM)
Clinical Trials.gov Identifier NCT02047097
Principal Investigator: Ellen M. Mowry, M.D.
Dr. Ellen Mowry is currently recruiting subjects for a study that will collect information on safety and document the drug utilization of Tecfidera (dimethyl fumarate) when used in patients with multiple sclerosis (MS). This study is being done to gain a better understanding of the benefits and risks of long-term treatment with Tecfidera in individuals with MS. Participants with MS who are newly starting treatment with Tecfidera as part of routine clinical care will be enrolled and followed for up to five years. Information on safety, side effects, relapses, disability progression, and the quality of life in individuals taking Tecfidera will be collected. Participantsare not expected to come to Johns Hopkins for visits other than those already scheduled with their MS clinical provider. In order to be eligible, participants must have MS and be planning to start Tecfidera soon. Participants must not have previously received Tecfidera (dimethyl fumerate), Fumaderm, or compounded fumarats at the time of enrollment. For more information, please contact Ama Avornu at firstname.lastname@example.org
Vitamin D Supplementation in Multiple Sclerosis
Clinical Trials.gov Identifier NCT001490502
Principal Investigator: Ellen M. Mowry, M.D.
Dr. Ellen Mowry is currently recruiting subjects for a study that will assess the effectiveness of vitamin D supplementation in patients with multiple sclerosis (MS). This trial is being done because previous studies of vitamin D levels in people with MS show that those with lower vitamin D levels are more likely to have MS attacks and new MS lesions develop on brain MRI, but it is not known if giving vitamin D supplements reduces the amount of MS activity. This is a multicenter trial in which participants with relapsing-remitting MS will be receive high-dose or low-dose vitamin D for two years. All participants will be given glatiramer acetate (Copaxone) for free during the study. The purpose of the study is to assess if vitamin D is effective in reducing relapses and new MRI lesions in people with multiple sclerosis.
In order to be eligible, participants must have relapsing-remitting MS who have had a certain number of relapses and new MRI lesions in the past one to two years. They must have no limitations in walking because of the MS. Participants must be aged 18 to 50. They must not have received Copaxone for more than 3 months in the past. They must not have been on natalizumab (Tysabri), fingolimod (Gilenya), or fumarate in the past six months and cannot have received any other unapproved MS therapy or chemotherapy. Participants must not have taken more than 1,000 IU/day of vitamin D3 in the three months before the first study visit. Those with certain other health conditions or taking certain medications will be excluded for the sake of safety.
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To request an appointment or refer a patient, please contact the Johns Hopkins Multiple Sclerosis Center at 410-614-1522.
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