Trial results for a study evaluating a Dual-task Augmented Reality Treatment (DART) protocol for Parkinson's Disease patients with deep brain stimulation were posted on 2025-09-30, reporting a mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score of 3.25 (Standard Deviation 3.27) and a mean Two Minute Walk Test score of 0.06 meters/second (Standard Deviation 0.15).
Background
Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms such as tremor, rigidity, bradykinesia, and postural instability. Deep Brain Stimulation (DBS) is a well-established surgical treatment for advanced PD that can significantly improve motor symptoms and quality of life for many patients. However, some symptoms, particularly postural instability and gait dysfunction (PIGD), can persist or emerge even after DBS implantation. These symptoms contribute significantly to falls and reduced mobility, impacting patient independence. Digital therapeutics, such as augmented reality protocols, are being explored as potential adjunctive treatments to address these challenging aspects of PD management in individuals already undergoing DBS therapy.
Trial design
This completed study, identified as Phase NA, enrolled 7 participants with Parkinson's Disease and Deep Brain Stimulation. The trial's goal was to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, the Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD who had a previously implanted deep brain stimulator (DBS).
Key results
The trial results included measurements for motor examination and gait performance:
- The Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score for the Interventional Arm showed a mean of 3.25 with a Standard Deviation of 3.27 (Score on a scale).
- The Two Minute Walk Test for the Interventional Arm showed a mean of 0.06 meters/second with a Standard Deviation of 0.15 (meters/second).
What this means
The posted results provide preliminary data on the use of a Dual-task Augmented Reality Treatment (DART) protocol for individuals with Parkinson's Disease who have previously undergone Deep Brain Stimulation. With a small enrollment of 7 participants, these findings are exploratory and aim to assess the safety and initial effectiveness of this digital therapeutic approach for postural instability and gait dysfunction. The reported mean scores for motor examination and the two-minute walk test offer initial insights into how this intervention might influence specific motor and gait parameters. Further research with larger cohorts would be necessary to determine the clinical significance and broader applicability of these findings for improving outcomes in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06418152, titled "Dual-task Augmented Reality for PD DBS", were posted on 2025-09-30 on clinicaltrials.gov.