Trial results for a study investigating cortical stimulation to treat mood and behavioral symptoms in Parkinson's Disease were posted on ClinicalTrials.gov on 2025-11-21, revealing significant effects on offer acceptance probability with a p-value of 0.0001.
Background
Parkinson's Disease is a progressive neurodegenerative disorder primarily affecting motor function, but it is also frequently associated with non-motor symptoms, including mood and behavioral disturbances. These non-motor symptoms can significantly impact a patient's quality of life. The investigation into cortical stimulation aims to explore potential therapeutic avenues for managing these complex symptoms.
Trial design
This completed study, designated as Phase NA, enrolled 5 participants with Parkinson's Disease. The study investigated cortical stimulation, specifically chronic neural recording with prefrontal cortex ECoG and chronic orbitofrontal cortex (OFC) stimulation, to treat mood and behavioral symptoms.
Key results
The study reported several key measurements and analyses:
- Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient): A beta coefficient of -0.175 was observed.
- Prefrontal Cortex Theta Power Relative to Previous Trial Reward (Beta Coefficient): A beta coefficient of 0.424 was observed.
- Effect of Reward Magnitude and Effort Cost on Offer Acceptance Probability:
- For reward magnitude, a beta coefficient of 1.05 was found.
- For effort cost, a beta coefficient of -2.37 was found.
- Association Between Prefrontal Cortex Beta Band Spectral Power and Mood Symptoms: A median Spearman correlation coefficient (r) of 0.415 (Full Range) was reported.
- Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings:
- Mean score on a scale: 23.23 (Standard Deviation 23.71)
- Mean score on a scale: 67.62 (Standard Deviation 23.59)
- Mean score on a scale: 19.15 (Standard Deviation 22.71)
- Mean score on a scale: 33.00 (Standard Deviation 30.35)
- Mean score on a scale: 71.06 (Standard Deviation 20.24)
- Mean score on a scale: 28.63 (Standard Deviation 28.45)
- Mean score on a scale: 2.31 (Standard Deviation 2.72)
Key statistical analyses included:
- A Mixed Models Analysis yielded a p-value of 0.007.
- Another Mixed Models Analysis yielded a p-value of 0.018.
- A generalized linear mixed model examining the effect of reward magnitude on the probability of accepting offers reported a p-value of 0.0001.
- A generalized linear mixed model examining the effect of effort cost on the probability of accepting offers reported a p-value of 0.0001.
What this means
The trial results suggest that cortical stimulation can significantly influence behavioral aspects related to reward processing and effort evaluation in patients with Parkinson's Disease, as indicated by the statistically significant p-values of 0.0001 for the effects of reward magnitude and effort cost on offer acceptance probability. The observed median Spearman correlation of 0.415 between prefrontal cortex beta band spectral power and mood symptoms also points to a potential neural correlate for mood regulation. While the mean scores for OFC stimulation on depression, anxiety, and energy ratings provide descriptive data, further research would be needed to establish their statistical significance and clinical impact.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03131817, titled "Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients", were posted on 2025-11-21 on clinicaltrials.gov.