DBS treatment may slow the progression of Parkinson's tremor in early-stage patients – ScienceDaily

] Neurology is important because it is the first evidence of a treatment that can delay the progression of one of the cardinal features of Parkinson's disease. However, the authors of the study strongly recommend that a larger scale clinical trial between multiple investigative centers be required to validate the discovery.

"The discovery around the tremor is truly exceptional," said David Charles, MD, professor and vice president of Neurology and senior author. "What this suggests is that SCP applied to the early stage of Parkinson's disease can slow the progression of tremors, which is remarkable because there is no cure for the disease." Parkinson's which slows the progression of any element of the disease. 19659003] Mallory Hacker, Ph.D., assistant professor of neurology and lead author of the study, analyzed the data collected during the trial started in 2006, a controversial essay because he was recruiting patients with early Parkinson's disease. At that time, DBS was approved only for advanced Parkinson's disease when symptoms were no longer adequately controlled by medication.

Hacker has been able to study this unique cohort in recent years. As part of the trial, patients agreed to be removed from their Parkinson's drug, and those who received DBS also agreed to disable their DBS stimulators, so that researchers could evaluate the progression of their underlying disease. The seven-day assessments were conducted at the VUMC Clinical Research Center every six months over a two-year period. An external evaluator noted the patients, observing videotapes of patients who were presented apart from the chronological order and without information on treatment assignment or whether the patients were under or off therapy. This single-blind evaluation of the motor characteristics of all their treatment of Parkinson's disease was the basis of the publication Neurology.

The DBS group was on average better on the overall motor part than the group treated with only medication. However, this conclusion was not statistically significant because the size of the study was limited by the FDA to 30 participants and therefore not powerful enough to determine the efficacy.

"As it was the first early DBS trial, it was not known whether there was" the post hoc analysis showed that 86 percent of patients developed a resting tremor in previously unaffected members during the two-year period. period, whereas this occurred only in 46% of patients who received treatment with DBS in addition to drug treatment. Four of the patients with DBS had resting tremor improvement and one resting tremor completely disappeared from all affected limbs for a DBS patient.

The FDA approved Vanderbilt to conduct the next early DBS trial, a large-scale, multi-center, Phase III trial. recruit 280 people with early Parkinson's disease. Seventeen other US medical centers have agreed to participate in this pivotal trial and have joined the DBS at the early stage of the Parkinson's study group. Hacker is executive director of the study group and the launch of this phase 3 study is expected to begin in 2019.

"This study on Parkinson's Tremor is an incredibly exciting discovery," said Charles. "We now need to conduct this FDA-approved trial, and we insist that patients should not seek DBS for Parkinson's disease at an early stage. We need to conduct a large, well-controlled multicentre trial exploring its safety." and its safety, effectiveness before drawing conclusions about the optimal stage of the disease to consider DBS therapy. "

DBS is generally applied in late-stage Parkinson's disease when drugs no longer control adequately the symptoms. In 2016, the FDA expanded the indications for DBS surgery to include patients with intermediate-stage Parkinson's disease, those who have been diagnosed for at least four years and who have developed motor complications that do not respond well. to drugs.

"The field of DBS therapy for Parkinson's disease is moving into the early stages of treatment, so we need to conduct pivotal testing to ensure patient safety and provide the Parkinson community with the best medical evidence for guide the treatment ". ] VUMC is one of the best DBS centers in the world, where a multidisciplinary team has provided therapy to more than 1,000 patients.