N/A
N=5
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03131817 ↗Enrolled (actual)
5
Serious AEs
40.0%
Results posted
Nov 2025
Primary outcome: Primary: Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient) — -0.175 beta coefficient — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic Activa PC+S System with Chronic Neural Recording (Device); Effort-Reward Decision-Making Task (Behavioral); Prefrontal Cortex Stimulation (Other); Tablet-Based Mood Tracking (Immediate Mood Scaler) (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Simon J. Little, MBBS, PhD
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient) |
-0.175 | 0.007 sig |
| PRIMARY Prefrontal Cortex Theta Power Relative to Previous Trial Reward (Beta Coefficient) |
0.424 | 0.018 sig |
| PRIMARY Effect of Reward Magnitude and Effort Cost on Offer Acceptance Probability |
1.05; -2.37 | <0.0001 sig |
| PRIMARY Association Between Prefrontal Cortex Beta Band Spectral Power and Mood Symptoms |
0.415 | — |
| PRIMARY Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings |
23.23; 67.62; 19.15; 33.00; 71.06; 28.63 | — |
| SECONDARY Effect of Prefrontal Cortex Stimulation on Acceptance Rate of Work Offers During Effort-Based Decision-Making Task |
9.646 | — |
Summary
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.
Eligibility Criteria
Inclusion Criteria
- Ability to give informed consent for the study
- Age 30-75
- Diagnosis of Parkinson's disease by a movement disorders specialist
- Movement disorder symptoms that are sufficiently severe, in the setting of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
- UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.
OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management OR Patients intolerant to medication causing significant functional disability
- Have one or several mild to moderate mood or impulsive behavior as defined by:
- depression (BDI>=13)
- anxiety (BAI >=7)
- impulsive behavior as indicated by a positive score on the Questionnaire for Impulsive-Compulsive disorders in Parkinson's Disease (QUIP-A) or as determined by clinical interview or informant report
- Mood or behavior symptom fluctuations corresponding to minimum 30% improvement in non-motor symptoms when comparing visual analogue scales (VAS) scores in the on versus off medication state
- Stable doses of anti-Parkinsonian medications for at least 30 days prior to their baseline assessment.
Exclusion Criteria
- Pregnancy or breast feeding
- MRI showing cortical atrophy out of proportion to age
- MRI showing focal brain lesions that could indicate a disorder other than idiopathic PD
- Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
- Any prior intracranial surgery except DBS surgery
- Significant cognitive impairment (MoCA<20).
- History of seizures
- Immunocompromised
- Has an active infection
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
- Inability to comply with study follow-up visits
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
Data sourced from ClinicalTrials.gov (NCT03131817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.