Trial results for a study investigating Parkinson's Disease, Deep Brain Stimulation, and Freezing of Gait were posted on ClinicalTrials.gov on 2025-11-04, with 15 participants enrolled.
Background
Parkinson's Disease is a progressive neurodegenerative disorder affecting movement, often characterized by tremors, rigidity, bradykinesia, and postural instability. A particularly debilitating symptom for many patients is Freezing of Gait (FOG), which involves sudden, brief episodes of inability to move the feet forward, often leading to falls and reduced quality of life. Deep Brain Stimulation (DBS) is a surgical treatment option for some individuals with Parkinson's Disease, involving the implantation of electrodes in specific brain areas to deliver electrical impulses that help control motor symptoms. Optimizing DBS programming to address complex symptoms like FOG remains an area of active research. This study utilized virtual reality technology to create controlled environments that trigger FOG, aiming to record brain signals and gain a deeper understanding of the neural mechanisms underlying these episodes to potentially improve DBS programming strategies.
Trial design
This completed study, for which the phase was not specified, enrolled 15 participants. The conditions investigated included Parkinson Disease, DBS, Deep Brain Stimulation, Freezing of Gait, and Virtual Reality. The trial's primary objective was to better understand what occurs in the brain during freezing of gait by having individuals who underwent DBS surgery for Parkinson's disease walk through a virtual reality environment while brain signals were recorded from the DBS device. No specific interventions were listed as being tested, as the study focused on observation and data collection for understanding a phenomenon, and no primary outcomes were specified.
Key results
The trial reported several key measurements related to freezing of gait and other gait parameters:
- Freezing of Gait episodes:
- In the "OFF DBS/OFF PD Meds" group, the mean was 2.6 (Standard Deviation 2.6) episodes.
- In the "OFF DBS/ON PD Meds" group, the mean was 1.5 (Standard Deviation 2.1) episodes.
- Gait Velocity (m/s):
- In the "OFF DBS/OFF PD Meds" group, the mean was 0.27 (Standard Deviation 0.06) m/s.
- In the "OFF DBS/ON PD Meds" group, the mean was 0.29 (Standard Deviation 0.07) m/s.
- Turn Velocity (degrees/s):
- In the "OFF DBS/OFF PD Meds" group, the mean was 21.7 (Standard Deviation 6.0) degrees/s.
- In the "OFF DBS/ON PD Meds" group, the mean was 22.1 (Standard Deviation 5.9) degrees/s.
What this means
The posted results provide observational data on freezing of gait episodes, gait velocity, and turn velocity in a small cohort of Parkinson's Disease patients with Deep Brain Stimulation. The measurements were taken under two conditions: "OFF DBS/OFF PD Meds" and "OFF DBS/ON PD Meds," offering insights into how medication might influence these gait parameters even when DBS is inactive. The data shows fewer freezing of gait episodes and slightly improved gait and turn velocities when patients were on their Parkinson's medications. This information contributes to the understanding of the characteristics of freezing of gait in a controlled virtual reality environment, which could potentially inform future strategies for optimizing DBS programming to mitigate this challenging symptom.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05103384, titled "Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming", were posted on 2025-11-04 on clinicaltrials.gov.