Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
Simon J. Little, MBBS, PhD
Study ID
NCT03131817
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Medtronic Activa PC+S System with Chronic Neural Recording — DEVICE
    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.
  • Effort-Reward Decision-Making Task — BEHAVIORAL
    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.
  • Prefrontal Cortex Stimulation — OTHER
    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.
  • Tablet-Based Mood Tracking (Immediate Mood Scaler) — BEHAVIORAL
    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.

Study Details

This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.

Key Dates

Start date
Dec 16, 2016
Status verified
Nov 2025
Primary completion
Jun 18, 2024
Completion
Jun 18, 2024

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chronic Neural Recording with Prefrontal Cortex ECoG in Parkinson's Disease
    Participants with Parkinson's disease underwent deep brain stimulation (DBS) lead implantation targeting either the subthalamic nucleus or globus pallidus internus for motor symptom management. A permanent 4-contact subdural electrocorticography (ECoG) strip was also placed over the right prefrontal cortex and connected to a Medtronic Activa PC+S neurostimulator. This setup enabled chronic recording of local field potentials from the prefrontal cortex during daily life and structured experimental tasks. Neural and behavioral data were collected through decision-making tasks and longitudinal self-report of mood and symptoms using a tablet-based tool. Clinical DBS and medication adjustments were performed solely as part of standard care and were not influenced by participation in the study.
  • Experimental: Prefrontal Cortex ECoG Stimulation in Parkinson's Disease
    A subset of participants in the recording cohort also received experimental stimulation through the implanted prefrontal ECoG strip. One participant underwent blinded, block-wise prefrontal cortex stimulation during a behavioral task to assess its causal effects on motivation and decision-making. Additionally, two participants received blinded, chronic prefrontal stimulation at home over a 14-day period, in conjunction with their ongoing subcortical motor DBS. These participants completed daily self-reports of mood and anxiety symptoms during the stimulation period. All stimulation protocols were experimental and distinct from routine motor DBS programming. Clinical DBS and medication adjustments were made exclusively as part of routine care and were not affected by the study procedures.

Primary Outcome Measure

Association Between Basal Ganglia Beta Power and Effort Level (Beta Coefficient) [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Surgical Movement Disorders CenterSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UCSF Surgical Movement Disorders Center· San Francisco, CA

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