Trial results for an adaptive Deep Brain Stimulation (aDBS) algorithm for Parkinson's Disease were posted on ClinicalTrials.gov on 2025-07-08, indicating that 91% of subjects in the dual threshold mode achieved "On" time without troublesome dyskinesia.
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 to deliver electrical impulses to specific brain areas. This study investigated an adaptive DBS (aDBS) algorithm, which aims to personalize therapy and potentially optimize outcomes, addressing the need for more tailored and efficient treatment approaches.
Trial design
This completed study, designated as Phase NA, enrolled 85 participants with Parkinson Disease. The trial's purpose was to demonstrate the safety and effectiveness of adaptive DBS (aDBS). The study evaluated two adaptive DBS modes: aDBS Single Threshold and aDBS Dual Threshold, with safety data also collected at a cDBS (conventional DBS) Baseline.
Key results
The trial reported key measurements related to the effectiveness and safety of adaptive DBS:
- Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold:
- In the Primary Cohort aDBS Single Threshold group, this proportion was 78.9%. The 97.5% confidence interval for this proportion had a lower bound of 59.4%.
- In the Primary Cohort aDBS Dual Threshold group, this proportion was 91%. The 97.5% confidence interval for this proportion had a lower bound of 75.6%.
- Stimulation Energy Use:
- For aDBS Single Threshold, the mean change in energy use was -22.3 micro Watts, with a p-value of 0.012, suggesting a statistically significant reduction compared to conventional DBS.
- For aDBS Dual Threshold, the mean change in energy use was -22.3 micro Watts, with a p-value of 0.0491, also indicating a statistically significant reduction compared to conventional DBS.
- Safety (Stimulation-related Adverse Events):
- 3 participants experienced stimulation-related adverse events at cDBS Baseline.
- 8 participants experienced stimulation-related adverse events in the aDBS Single Threshold Mode.
- 5 participants experienced stimulation-related adverse events in the aDBS Dual Threshold Mode.
What this means
The results suggest that adaptive Deep Brain Stimulation (aDBS) may offer significant benefits for patients with Parkinson's Disease. The high proportion of subjects achieving "On" time without troublesome dyskinesia, particularly the 91% in the dual threshold mode, indicates improved motor control and quality of life. The statistically significant reduction in stimulation energy use by -22.3 micro Watts for both aDBS modes is also a notable finding, potentially leading to extended battery life for implanted devices and fewer procedures for battery replacement. While the number of stimulation-related adverse events was higher in aDBS modes compared to the cDBS baseline, further context on the nature and severity of these events would be necessary for a comprehensive safety assessment.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04547712, titled "Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease", were posted on 2025-07-08 on clinicaltrials.gov.