A trial evaluating burst-type Deep Brain Stimulation (DBS) for Parkinson's Disease was terminated, with results posted on ClinicalTrials.gov on 2025-05-28. The study enrolled only 2 participants, limiting the interpretability of the reported measurements.
Background
Parkinson's Disease is a progressive neurodegenerative disorder affecting movement. Deep Brain Stimulation (DBS) is an established surgical treatment for advanced Parkinson's Disease, involving the implantation of electrodes in specific brain areas to deliver electrical impulses that help control motor symptoms. Standard DBS typically uses high-frequency continuous stimulation. Burst-type DBS is a novel stimulation protocol that delivers intermittent bursts of traditional high-frequency stimulation, hypothesized to potentially improve the efficacy and durability of DBS pulse generators compared to standard programming.
Trial design
This study was designed to evaluate burst-type electrical stimulation programming versus standard DBS programming in patients with Parkinson Disease who were also undergoing Deep Brain Stimulation. The trial was designated as Phase NA and was terminated with an enrollment of 2 participants. The trial aimed to assess whether burst-type DBS could improve the efficacy and durability of DBS. The study's brief summary indicated an evaluation of burst-type programming versus standard programming, with participants receiving experimental burst-type programming first, followed by baseline programming.
Key results
Due to the termination of the study and the limited enrollment of 2 participants, the reported measurements represent observations from a very small group and are not generalizable. The Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores were reported at various time points:
- At Baseline (Visit 1) for the group receiving Experimental Burst-type Programming First, Then Baseline Programming, observed median scores were 55.5, 20, and 32.
- At Six Months (Visit 2) for the group receiving Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1), an observed median score was 25.
- At Twelve Months (Visit 3) for the group receiving Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1), an observed median score was 26.
These scores are individual observations rather than aggregated statistical results from a larger cohort.
What this means
The termination of this trial and its very limited enrollment of 2 participants mean that no definitive conclusions can be drawn regarding the efficacy or durability of burst-type Deep Brain Stimulation for Parkinson's Disease. While individual UPDRS v-III motor examination scores were reported, these observations are from an insufficient sample size to establish any clinical significance or generalizable findings. Further research with adequate enrollment and completion would be necessary to evaluate the potential benefits of burst-type DBS programming.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05753449, titled "Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease", were posted on 2025-05-28 on clinicaltrials.gov.