Adults 30 to 75, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient)Primary· Single recording session per participant (approximately 90 minutes total; 3 blocks of 25 trials each), with outcome assessed at each trial and data aggregated across all trials for all participants.
Mean beta-band (12-20 Hz) oscillatory power in the basal ganglia (BG) during the decision period, analyzed as a function of the current trial effort level during the reward-effort decision-making task.
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
-0.175
Prefrontal Cortex Theta Power Relative to Previous Trial Reward (Beta Coefficient)Primary· Single recording session per participant (approximately 90 minutes total; 3 blocks of 25 trials each), with outcome assessed at each trial and data aggregated across all trials for all participants.
Mean theta-band (4-7 Hz) oscillatory power in the prefrontal cortex (PFC) was assessed during the decision period of each trial. Theta power was modeled as a function of the reward received in the previous trial using linear mixed-effects models. The analysis included trials from structured decision-making task sessions.
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
0.424
Effect of Reward Magnitude and Effort Cost on Offer Acceptance ProbabilityPrimary· Single recording session per participant (approximately 90 minutes total; 3 blocks of 25 trials each), with outcome assessed at each trial and data aggregated across all trials for all participants.
This outcome measures the effect of reward magnitude and effort cost on the probability of participants accepting offers during a decision-making task. Effects were assessed using generalized linear mixed models (LMMs) to estimate the relationship between reward, effort, and choice behavior.
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
-2.37
Association Between Prefrontal Cortex Beta Band Spectral Power and Mood SymptomsPrimary· Daily paired assessments of neural recordings and IMS scores over 3-5 months for each participant.
This outcome measures the association between prefrontal cortex (PFC) beta band spectral power recorded via chronic subdural ECoG and self-reported symptoms of depression and anxiety assessed using standardized scales. Associations were evaluated using Spearman correlation coefficients calculated for each participant. The Beck Depression Inventory (BDI) ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. The Beck Anxiety Inventory (BAI) ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
0.415
0.31 – 0.48
Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy RatingsPrimary· Daily paired assessments of neural recordings and IMS scores over 14 days for each participant.
This outcome measures self-reported symptoms of depression, anxiety, and energy levels in participants undergoing chronic orbitofrontal cortex (OFC) stimulation at home. Participants received blinded OFC stimulation for 14 days, with alternating sham and active stimulation days. Symptoms were assessed daily using visual analogue scales (VAS) for depression, anxiety, and energy, as well as the Hamilton Depression Rating Scale (HAM-D). The VAS ranges from 0 to 100. For the depression and anxiety VAS, higher scores indicate worse symptoms, whereas for the energy VAS, higher scores indicate greate
VAS Anxiety Score (Sham Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
23.23
± 23.71
VAS Energy Score (Sham Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
67.62
± 23.59
VAS Depression Score (Sham Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
19.15
± 22.71
VAS Anxiety Score (Active Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
33.00
± 30.35
VAS Energy Score (Active Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
71.06
± 20.24
VAS Depression Score (Active Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
28.63
± 28.45
HAM-D Score (Sham Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
2.31
± 2.72
HAM-D Score (Active Condition)
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
2.25
± 2.96
Effect of Prefrontal Cortex Stimulation on Acceptance Rate of Work Offers During Effort-Based Decision-Making TaskSecondary· Six recording blocks (three with stimulation On and three with stimulation Off), each approximately 15 minutes in duration (total ~90 minutes), with outcome assessed on each trial and data aggregated across both conditions for the participant.
Measured the effect of high-frequency prefrontal cortex (PFC) stimulation on the acceptance rate of work offers during an effort-based decision-making task in one participant (PD5). Stimulation was delivered in a single-blinded, randomized, counterbalanced block-wise design at an amplitude below detectability threshold and without motor effects. Acceptance rate was modeled using a linear mixed model with stimulation condition (On vs Off) as a fixed effect.
Group
Value
95% CI
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
9.646
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment until study exit (defined as device explantation or study withdrawal), up to 7 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
Serious: 2/5 (40%)
Deaths: 0/5
Serious adverse events (2 terms)
Reaction
System
Chronic Neural Recording W…
DBS lead migration requiring repositioning surgery
Injury, poisoning and procedural complications
—
Prolonged hospitalization with cognitive and executive dysfunction
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Simon J. Little, MBBS, PhD
Last refreshed: 21 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03131817.