Massive Study Begins on ITB Therapy to Treat Spasticity After Brain, Spinal Cord Injury, and Stroke

Medtronic, Inc. recently began enrolling European stroke patients into clinical trials for Intrathecal Baclofen (ITB) therapy to treat spasticity that has otherwise proven unresponsive to treatment. While the study is restricted to stroke patients, spasticity affects patients with other conditions as well. A PR Newswire release reported that ITB treatment has already been approved for use in patients with spasticity issues due to “multiple sclerosis, cerebral palsy, spinal cord injury, brain injury, and stroke that do not respond to oral medication.”
ITB treatment medicates against spasticity by way of a pump placed under the skin of the torso and connected to a catheter. Medicine to stop spasticity is delivered into the spinal fluid, which means a much lower dose of baclofen can be administered than when taken orally. The lead investigator of the SISTERS study (Spasticity in STrokE Randomised Study), Professor Leopold Saltuari said, “ITB Therapy has the potential to restore quality of life in patients whose lives have been completely disrupted by a stroke and the impairing and debilitating symptoms of spasticity. With this study we are aiming to demonstrate that there is a way to manage spasticity for many of them,” in the PR Newswire release.
Previous clinical trials have demonstrated the effectiveness of ITB in reducing spasticity in 89 percent of patients who received the treatment over six months. “The primary endpoint is the reduction of spasticity after six months of treatment with ITB Therapy and physical therapy compared to patients treated with one or more oral medications and physical therapy,” the article continued. Spinal cord injury and multiple sclerosis patients who took part in earlier studies showed a 92 percent decrease in spasticity symptoms after receiving ITB therapy.
However, the therapy may not be for everyone. The side effects, while usually temporary, include “loose muscles, drowsiness, nausea/vomiting, headache and dizziness,” the article said. In addition, sudden stopping of the medication can lead to “high fever, altered mental status, returned spasticity, and muscle rigidity, and in rare cases has been fatal,” the article continued. Check with your doctor to learn more about ITB.