Trial results for a terminated study investigating Parkinson's Disease were posted on ClinicalTrials.gov on 2025-07-03. The study, which explored caloric vestibular stimulation, enrolled 148 participants and reported a mean change of -23.12 in the International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) total score for the Randomized Controlled Trial (RCT) Passive Treatment group.
Background
Parkinson's Disease (PD) is a chronic and progressive neurodegenerative disorder primarily affecting motor function, but also associated with a wide range of non-motor symptoms such as sleep disturbances, mood disorders, and cognitive impairment. These non-motor symptoms can significantly impact a patient's quality of life. Current treatments largely focus on managing motor symptoms, often through dopaminergic medications, but there remains an unmet need for effective therapies addressing the broader spectrum of PD symptoms, particularly non-motor aspects. This study aimed to assess the safety and efficacy of an extended caloric vestibular stimulation treatment for PD symptoms.
Trial design
This study, designated as Phase NA, was ultimately TERMINATED after enrolling 148 participants. It investigated conditions including Parkinson Disease and Parkinson's Disease and Parkinsonism. The trial's brief summary indicated an aim to establish the safety and efficacy of extended twice daily time-varying caloric vestibular stimulation treatments for symptoms associated with Parkinson's disease. Only participants who completed a preceding randomized controlled trial (NCT04797611) were eligible for this open-label extension portion. The study did not list specific primary outcomes in the posted results.
Key results
The trial reported several key measurements related to motor and non-motor symptoms:
- Change From Baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score (change in score on a scale from baseline):
- For the Randomized Controlled Trial (RCT) Passive Treatment group, the mean change was -23.12.
- For the Open Label Extension (OLE) Active Treatment group, the mean change was 3.28.
- Change From Baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (change in score on a scale from baseline):
- For the Randomized Controlled Trial (RCT) Passive Treatment group, the mean change was -0.03.
- For the Open Label Extension (OLE) Active Treatment group, the mean change was 0.60.
- Change From Baseline in the Clinical Global Impression - Improvement (CGI-I) (Participants):
- For the Randomized Controlled Trial (RCT) Passive Treatment group, participant counts were reported as 0, 12, 22, and 23.
- For the Open Label Extension (OLE) Active Treatment group, participant counts were reported as 0, 10, 23, and 17.
What this means
The posted results from this terminated study present mixed findings regarding the impact of caloric vestibular stimulation on Parkinson's Disease symptoms. A notable mean reduction of -23.12 in the MDS-NMS total score was observed in the RCT Passive Treatment group, suggesting an improvement in non-motor symptoms. However, the OLE Active Treatment group showed a mean increase of 3.28 in the same scale, indicating a worsening. Similarly, motor symptoms, as measured by MDS-UPDRS Part II, showed a minimal mean change of -0.03 in the RCT Passive Treatment group and a slight mean increase of 0.60 in the OLE Active Treatment group. The termination of the trial, coupled with these divergent outcomes between the passive and active treatment groups, suggests that further research is needed to clarify the efficacy and safety profile of this intervention for Parkinson's Disease.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public registry of clinical studies. The results for the study NCT04799418, titled "STEM-PD Open Label Extension (OLE)", were posted on 2025-07-03 on clinicaltrials.gov.