At a glance
ClinicalIndex Comparison Record- ✓Age 30-75 years
- ✓Parkinson's disease diagnosed by movement disorders specialist
- ✓Motor symptoms severe enough to warrant DBS surgery per standard clinical criteria, with UPDRS-III off-medication score 20-80 and ≥30% improvement on medication, OR tremor-dominant PD with tremor score ≥2 and treatment resistance, OR medication intolerance
- ✓Mild to moderate mood or impulsive behavior: depression (BDI ≥13), anxiety (BAI ≥7), impulsivity (positive QUIP-A or clinical assessment), or mood fluctuations with ≥30% improvement in VAS scores on versus off medication
- ✕Pregnancy or breastfeeding
- ✕MRI showing cortical atrophy out of proportion to age
- ✕MRI showing focal brain lesions indicating disorder other than idiopathic PD
- ✕Major comorbidity increasing surgical risk: prior stroke, severe hypertension, severe diabetes, or chronic anticoagulation other than aspirin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's
In Brief
A clinical study evaluating Medtronic Activa PC+S System with Chronic Neural Recording, Effort-Reward Decision-Making Task, and 2 other interventions for Parkinson's Disease. Completed, enrolled 5 participants across 1 site.
Detailed Summary
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.
Study Details
Timeline
Interventions
Participants received a Medtronic Activa PC+S system incorporating standard-of-care DBS leads implanted in the basal ganglia (subthalamic nucleus or globus pallidus internus) for management of Parkinson's disease motor symptoms. Additionally, a permanent 4-contact subdural electrocorticography (ECoG) strip was implanted over the prefrontal cortex (e.g., dorsolateral, orbitofrontal, or frontopolar regions) to enable chronic recording of local field potentials. The system allowed for long-term, wireless neural recordings in naturalistic or task-based conditions.
Participants performed a structured task involving repeated choices to accept or reject offers requiring different levels of physical effort in exchange for variable rewards. The task was used to assess motivation and effort-based valuation processes.
In one participant, high-frequency stimulation was delivered to the prefrontal cortex via the ECoG strip during a behavioral paradigm. Stimulation was alternated On and Off in a blinded block-wise fashion during the behavioral task to assess causal effects on motivated behavior. In two patients, orbitofrontal cortex (OFC) stimulation was also assessed chronically at home in a within subject, repeated design.
Participants used a tablet-based Immediate Mood Scaler (IMS) to self-report symptoms related to depression and anxiety in real-time, naturalistic settings. These repeated, in-the-moment assessments were temporally paired with prefrontal cortical recordings to study physio markers of mood fluctuations over several months. No stimulation was delivered through the prefrontal cortex electrode.