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Clinical trials are studies designed to find new and better ways to treat patients with neuropathy. The physicians at the Maryland Peripheral Neuropathy Center are currently conducting the clinical trials listed below.

For more information on our studies, please contact either

Open Trials

IMABIN STUDY

Improving Autonomic Function and Balance in Diabetic Neuropathy (IMABIN STUDY)

Investigators at the VA Maryland Health Care System and University of Maryland (Drs. James Russell and Lindsay Zilliox) are conducting a study for patients with type II diabetes or prediabetes who also have neuropathy (damage to nerves in their legs or the nerves that control heart function or blood pressure).

In the Improving Autonomic Function and Balance in Diabetic Neuropathy (IMABIN Study), participants could have problems with their nerves and/or problems with their balance. We are recruiting participants for a 1-year trial to compare two lifestyle interventions and to determine if the interventions improve neuropathy and balance.

A preliminary study has suggested that a lifestyle intervention may help patients with mild nerve disease. Participants will be randomized into one of two groups (put into one of the two groups by the flip of a coin). Both groups will receive an intervention to improve their lifestyle but the interventions will be different in the two groups. The interventions focus on improving mobility, balance and nutrition.

The Participants will come to Baltimore City for part of their care. Patients will be reimbursed for the study. Some meals will be provided. Patients will receive free testing, and nutrition and exercise counseling on nutrition, exercise, and balance as part of this trial.

If you are interested in participating in the study and can answer yes to all the inclusion criteria below, you may be eligible for inclusion in the study. Please contact Ms. Kristin Fleishmann at 410-328-6583 or INMED@som.umaryland.edu.

Essential Screening Criteria

Please answer yes or no to the following questions:

  • Age 30-80 years?
  • Prediabetes or early controlled diabetes?
  • Otherwise medically stable?
  • Have no cause for neuropathy other than prediabetes or diabetes?
  • Willing to accept assignment to either intervention group?

For more about the study, visit the study's page on clinicaltrials.gov.

Metabolic Syndrome and Fall Risk

Investigators at the VA Maryland Health Care System and University of Maryland (Dr. Lindsay Zilliox and Dr. James Russell) are conducting a study for patients with Metabolic Syndrome who also have peripheral or autonomic neuropathy. The autonomic nervous system helps to control heart rate and blood pressure. Neuropathy is any disease of the peripheral nerves, and is damage to nerves in their legs or the nerves that control heart function or blood pressure.

The purpose of this project is to see if an exercise program can reduce fall risk in people with the metabolic syndrome (MetS) and autonomic neuropathy. The MetS is a set of risk factors for heart disease and diabetes that includes fat in the stomach area, high blood pressure, high cholesterol, and high blood sugar.

Participants will be randomized into one of two groups (put into one of the two groups by the flip of a coin). Both groups will receive an intervention to improve their lifestyle but the interventions will be different in the two groups. The interventions focus on improving balance and general health. Participants will come to the Baltimore VA Medical Health Center and will be reimbursed for the study. Some meals will be provided. Patients will receive free testing, and free tailored balance exercise classes or health classes as part of the study.

Essential Screening Criteria

Please answer yes or no to the following questions:

  • Age 45-75 years?
  • High blood pressure, high cholesterol, or high blood sugar?
  • Otherwise medically stable?
  • Have no cause for neuropathy other than prediabetes or diabetes?
  • Willing to accept assignment to either intervention group?

Learn more about this study on the clinicaltrials.gov page.

CAP-PRI

The validation of the CAP-PRI (chronic acquired polyneuropathy-patient reported index) in patients with acquired and idiopathic polyneuropathy

The CAP-PRI is a quality of life (QoL) measure that was recently generated and validated in a population of patients with chronic immune-mediated polyneuropathies (CIP) including chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), monoclonal gammopathy of undetermined significance (MGUS)-associated demyelinating polyneuropathy, and distal acquired demyelinating symmetric neuropathy (DADS).

Initially a 20-item instrument was generated from patient input and expert opinion. The 20-item instrument was rigorously studied with both modern and conventional psychometric analysis. It demonstrated excellent correlation with the Rasch Overall Disability Sum Score (R-ODS), INCAT disability scale, RAND-36, and Neuropathy Impairment Scale. It was then modified to the current 15-item measure with 3 response categories.

The 15-item CAP-PRI was recently validated in 39 subjects with CIP. At present there is no universally accepted QoL instrument used in clinical trials for patients with acquired polyneuropathies. Most QoL measures are generic and fail to capture relevant, disease-specific information.

Neuromuscular Database

Neuromuscular disorders, such as neuropathy, motor neuron disease and myopathy are common neurologic disorders that cause significant morbidity in the population. Establishing a database consisting of clinical information such as patient reported symptoms and clinician findings on physical exam facilitates further understanding of neuromuscular disorders.

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