Trial results for a study investigating central neurophysiologic correlates of non-motor symptoms, including depression, in Parkinson's disease were posted on ClinicalTrials.gov on 2025-05-21, with 30 participants enrolled.
Background
Parkinson's disease is characterized by motor symptoms, but non-motor symptoms such as depression and autonomic dysfunction significantly impact patient quality of life. Effective strategies to address these non-motor symptoms are crucial. Transcranial magnetic stimulation (TMS) is being explored as a potential intervention, and understanding its neurophysiologic correlates is an important step in determining its feasibility for treatment.
Trial design
This completed study, designated as Phase NA, enrolled 30 participants to investigate conditions including Parkinson Disease, Autonomic Dysfunction, and Depression. The trial was a randomized, single-blinded, triple crossover study focused on determining the feasibility of using transcranial magnetic stimulation (TMS) for treatment of Parkinson's disease related autonomic dysfunction and depression. Participants underwent TMS to three brain regions: medial prefrontal cortex (mPFC) (experimental site), dorsolateral prefrontal cortex (DLPFC) (alternative experimental site), or primary sensory cortex (S1) (control site).
Key results
The trial reported several key measurements related to changes in frontal midline theta EEG power after brain stimulation and correlations with autonomic scales:
- Change in Frontal Midline Theta EEG Power After Brain Stimulation:
- For Medial Prefrontal Cortex Stimulation, the mean change was 1.03 microvolts^2/Hz (Standard Deviation 2.41).
- For Dorsolateral Prefrontal Cortex Stimulation, the mean change was 0.44 microvolts^2/Hz (Standard Deviation 2.55).
- For Control Site Stimulation, the mean change was 1.01 microvolts^2/Hz (Standard Deviation 2.13).
- Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG for Stimulation Naiive participants was a Spearman Correlation coefficient of 0.255.
- Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG for Stimulation Naiive participants was a Spearman Correlation coefficient of 0.261.
- Correlation Between Degree of Orthostatic Hypotension and EEG for Stimulation Naiive participants was a Spearman Correlation coefficient of 0.429.
Several analyses were also reported:
- A Wilcoxon (Mann-Whitney) test reported a p-value of 0.08.
- Another Wilcoxon (Mann-Whitney) test reported a p-value of 0.54.
- A third Wilcoxon (Mann-Whitney) test reported a p-value of 0.03.
- An ANOVA test reported a p-value of 0.98.
- Another ANOVA test reported a p-value of 0.41.
- A third ANOVA test reported a p-value of 0.63.
What this means
The posted results provide initial neurophysiological data from a feasibility study exploring transcranial magnetic stimulation for non-motor symptoms, including depression and autonomic dysfunction, in Parkinson's disease. The measurements detail changes in EEG power across different stimulation sites and correlations between EEG and autonomic dysfunction scales. While a significant p-value of 0.03 was reported in one analysis, the specific clinical implications for depression or autonomic dysfunction require further investigation, as the p-values are not directly linked to specific outcome measures in the provided data. These findings contribute to understanding the central neurophysiologic correlates of TMS 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 NCT05205772, titled "Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease", were posted on 2025-05-21 on clinicaltrials.gov.