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

Summary

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

Conditions

• Parkinson's Disease

Interventions

DEVICE

Medtronic Activa PC+S System with Chronic Neural Recording

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.

BEHAVIORAL

Effort-Reward Decision-Making Task

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.

OTHER

Prefrontal Cortex Stimulation

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.

BEHAVIORAL

Tablet-Based Mood Tracking (Immediate Mood Scaler)

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.

Sponsors & Collaborators

• Simon J. Little, MBBS, PhD

  lead OTHER

Principal Investigators

• Simon Little, PhD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-16

Primary Completion

2024-06-18

Completion

2024-06-18

FDA Device

Yes

Countries

• United States

Study Locations