Trial results for a study investigating a non-invasive brainstem neuromodulation device for Parkinson's Disease were posted on ClinicalTrials.gov on 2025-08-14. The study, which was terminated, enrolled 15 participants.
Background
Parkinson's Disease is a progressive neurodegenerative disorder affecting movement. While current treatments primarily focus on managing motor symptoms, understanding the underlying mechanisms, particularly neurovascular status, is an active area of research. This study aimed to elucidate the mechanism of action for symptomatic benefits that have been observed with a non-invasive brainstem neuromodulation device in Parkinson's Disease, suggesting a focus on the physiological changes rather than direct clinical efficacy in this particular trial.
Trial design
This study, designated as Phase NA, was a single-site, double-blinded, randomized clinical trial that was terminated. It enrolled 15 participants with Parkinson Disease. The trial investigated the use of a non-invasive brainstem neuromodulation device, with the primary objective to elucidate its mechanism(s) of action for observed symptomatic benefits. Key measurements were collected across two groups, designated as Treatment 1 and Treatment 2, though specific intervention details for each group were not provided in the primary outcomes or interventions sections.
Key results
The trial reported several key measurements related to cerebral blood flow, cerebrovascular reactivity, and functional connectivity:
- Cerebral Blood Flow (CBF) Perfusion (ml/100g/min):
- For Treatment 1, a mean of 35.5 (Standard Deviation 4.76) was observed.
- For Treatment 2, a mean of 35.2 (Standard Deviation 5.94) was observed.
- Another measurement for Treatment 1 showed a mean of 33.6 (Standard Deviation 3.77).
- Another measurement for Treatment 2 showed a mean of 33.3 (Standard Deviation 10.38).
- Cerebrovascular Reactivity (% change CBF/change in CO2 (mmHg)):
- For Treatment 1, a mean of 1.01 (Standard Deviation NA) was observed.
- For Treatment 2, a mean of -1.39 (Standard Deviation 1.57) was observed.
- Another measurement for Treatment 1 showed a mean of -1.94 (Standard Deviation NA).
- Another measurement for Treatment 2 showed a mean of -0.7 (Standard Deviation 0.96).
- Percent Change in Functional Connectivity (Percent Change in Default Mode Network):
- For Treatment 1, a mean of 1.1 (Standard Deviation 21.8) was observed.
- For Treatment 2, a mean of 7.5 (Standard Deviation 19.2) was observed.
What this means
The posted results provide specific measurements for cerebral blood flow, cerebrovascular reactivity, and functional connectivity in a small cohort of Parkinson's Disease patients who participated in a terminated mechanistic study. While these data offer insights into various neurovascular parameters and brain network activity under different treatment conditions, the absence of comparative analyses, statistical significance, or a defined primary endpoint means that no direct conclusions can be drawn regarding the efficacy or specific impact of the non-invasive brainstem neuromodulation device. The termination of the study also limits the interpretability of these preliminary findings for clinical practice.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04598828, titled "Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease", were posted on 2025-08-14 on clinicaltrials.gov.