Trial Outcomes & Findings for Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients (NCT NCT03131817)
NCT ID: NCT03131817
Last Updated: 2025-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
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.
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Overall Study
STARTED
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5
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Overall Study
Enrollment and Implantation
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5
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Overall Study
Participant developed cognitive decline and was unable to provide regular symptom assessments
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1
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Baseline Characteristics
One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
Baseline characteristics by cohort
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=4 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Age, Categorical
<=18 years
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Age, Categorical
Between 18 and 65 years
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2 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Age, Categorical
>=65 years
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2 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Age, Continuous
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61 years
STANDARD_DEVIATION 7 • n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Sex: Female, Male
Female
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3 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Sex: Female, Male
Male
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1 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
Asian
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1 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
Black or African American
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
White
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2 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
More than one race
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0 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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Region of Enrollment
United States
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4 participants
n=68 Participants • One participant developed cognitive decline and was unable to provide regular symptom assessments and was excluded from final analysis.
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PRIMARY outcome
Timeframe: 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.Population: Five participants were enrolled in the study. However, one participant developed cognitive decline during the study and was unable to provide regular symptom assessments, so only four participants were included in the final analysis.
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.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=4 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient)
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-0.175 beta coefficient
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PRIMARY outcome
Timeframe: 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.Population: Five participants were enrolled in the study. However, one participant developed cognitive decline during the study and was unable to provide regular symptom assessments, so only four participants were included in the final analysis.
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.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=4 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Prefrontal Cortex Theta Power Relative to Previous Trial Reward (Beta Coefficient)
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0.424 beta coefficient
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PRIMARY outcome
Timeframe: 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.Population: Five participants were enrolled in the study. However, one participant developed cognitive decline during the study and was unable to provide regular symptom assessments, so only four participants were included in the final analysis.
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.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=4 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Effect of Reward Magnitude and Effort Cost on Offer Acceptance Probability
Reward magnitude effect (higher reward, higher acceptance)
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1.05 beta coefficient
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Effect of Reward Magnitude and Effort Cost on Offer Acceptance Probability
Effort cost effect (higher effort, lower acceptance)
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-2.37 beta coefficient
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PRIMARY outcome
Timeframe: Daily paired assessments of neural recordings and IMS scores over 3-5 months for each participant.Population: Five participants were enrolled in the study. However, one participant developed cognitive decline during the study and was unable to provide regular symptom assessments, so only four participants were included in the final analysis.
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.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=4 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Association Between Prefrontal Cortex Beta Band Spectral Power and Mood Symptoms
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0.415 Spearman correlation coefficient (r)
Interval 0.31 to 0.48
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PRIMARY outcome
Timeframe: Daily paired assessments of neural recordings and IMS scores over 14 days for each participant.Population: Five participants were enrolled in the study. 2 participants completed this (1 participant dropped out of research activities, 1 declined and 1 moved away from the study centre and so couldn't be followed).
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 greater energy. The HAM-D ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=2 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Anxiety Score (Sham Condition)
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23.23 score on a scale
Standard Deviation 23.71
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Energy Score (Sham Condition)
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67.62 score on a scale
Standard Deviation 23.59
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Depression Score (Sham Condition)
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19.15 score on a scale
Standard Deviation 22.71
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Anxiety Score (Active Condition)
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33.00 score on a scale
Standard Deviation 30.35
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Energy Score (Active Condition)
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71.06 score on a scale
Standard Deviation 20.24
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
VAS Depression Score (Active Condition)
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28.63 score on a scale
Standard Deviation 28.45
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
HAM-D Score (Sham Condition)
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2.31 score on a scale
Standard Deviation 2.72
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Effect of Chronic Orbitofrontal Cortex (OFC) Stimulation on Depression, Anxiety, and Energy Ratings
HAM-D Score (Active Condition)
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2.25 score on a scale
Standard Deviation 2.96
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SECONDARY outcome
Timeframe: 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.Population: One participant performed the decision-making task with PFC stimulation alternated On and Off between blocks.
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.
Outcome measures
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=1 Participants
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Effect of Prefrontal Cortex Stimulation on Acceptance Rate of Work Offers During Effort-Based Decision-Making Task
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9.646 beta coefficient
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Adverse Events
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=5 participants at risk
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Injury, poisoning and procedural complications
DBS lead migration requiring repositioning surgery
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20.0%
1/5 • Number of events 1 • From enrollment until study exit (defined as device explantation or study withdrawal), up to 7 years.
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General disorders
Prolonged hospitalization with cognitive and executive dysfunction
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20.0%
1/5 • Number of events 3 • From enrollment until study exit (defined as device explantation or study withdrawal), up to 7 years.
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Other adverse events
| Measure |
Chronic Neural Recording With Prefrontal Cortex ECoG in Parkinson's Disease
n=5 participants at risk
Participants with Parkinson's disease underwent implantation of deep brain stimulation (DBS) leads targeting the basal ganglia (subthalamic nucleus or globus pallidus internus) for motor symptom management, along with a permanent 4-contact subdural electrocorticography (ECoG) strip placed over the right prefrontal cortex. The ECoG strip was connected to a Medtronic Activa PC+S neurostimulator to enable chronic recording of local field potentials from the prefrontal cortex during everyday life and experimental tasks. All participants contributed neural and behavioral data, either during structured decision-making tasks or through longitudinal self-tracking of mood and symptoms using a tablet-based tool. One participant also underwent blinded, block-wise prefrontal cortex stimulation via the ECoG strip during a behavioral task to assess causal effects on motivation and decision-making. Two patients tested at home blinded chronic Prefrontal stimulation over 14 days in addition to their subcortical motor stimulation and provided self report ratings of mood and anxiety. Clinical DBS and medication adjustments were made only as part of routine care and not influenced by study participation.
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Injury, poisoning and procedural complications
Cortical lead migration detected post-surgery
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20.0%
1/5 • Number of events 1 • From enrollment until study exit (defined as device explantation or study withdrawal), up to 7 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place