Intraoperative Analysis of Reward and Impulsivity in the Basal Ganglia

Parkinson's Disease Clinical Trial

Official title:

Intraoperative Analysis of Reward and Impulsivity in the Basal Ganglia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319694
• Other study ID #: Pro00045557
• Secondary ID: R21NS084176
• Status: Completed
• Start date: July 2013
• Est. completion date: February 27, 2017

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project studies the impulsive side effects of common treatments for Parkinson's Disease. By learning how parts of the brain involved in Parkinson's encode information related to reward and motivation, the investigators will better understand the reasons why Parkinson's patients often suffer from compulsive gambling, hypersexuality, and repetitive tinkering ("punding"). These results may lead to the design of better methods of deep brain stimulation (DBS) that minimize the behavioral side effects of Parkinson's treatment.

Description:

While the typical treatments for Parkinson's disease (PD), dopaminergic drugs and deep brain stimulation (DBS), are proven to be effective in mitigating the motor deficits associated with the disease, these same methods also give rise to behavioral side effects including compulsive gambling, hypersexuality, and complex, purposeless stereotyped behavior ("punding"). And while much work has investigated the underlying patterns of neural activity giving rise to tremor, rigidity, and other motor effects of D, little is known about the neural genesis of impulsive side effects in humans. The investigators propose to characterize the patterns of neural activity underlying these failures of impulse control in an actual PD patient population undergoing surgery for the implantation of DBS electrodes. Such procedures offer a unique opportunity to collect data at the single neuron level in humans, since surgeons rely on intraoperative electrophysiology to identify the anatomical boundaries of the subthalamic nucleus (STN), the typical target of DBS in PD. Using multi-channel Ad-Tech microwire arrays, the investigators will simultaneously record multiple channels of single unit activity (both spikes and field potentials ) in STN and nearby structures while subjects perform cognitive tasks with validated links to impulsivity in human populations. In the balloon analogue risk task (BART) participants must balance risk and reward as they decide when to stop inflating a computerized balloon whose point value and risk of popping both grow with size. In the stop signal reaction task (SSRT), participants must respond as quickly as possible when a "go" cue appears, but countermand this response when a "stop" tone is played. At the neural level, the BART allows us to elucidate correlates of risk, outcome (both rewarding and aversive), and anticipation, while the SSRT, a well-studied model of impulsivity in both animal models and humans with strong links to computational models, will allow us to determine not only single unit but network-level patterns of activity underlying failures in impulse control. Through these experiments, as well as computational modeling, the investigators will characterize neural correlates of impulsivity in PD patients that will allow for the design of DBS protocols that mitigate impulsive side effects. The R21 mechanism will be used to further develop and streamline the process of multichannel recording and cognitive testing in the intraoperative setting and validate the hypothesized link between single neuron activity and models of behavior in the stop signal task.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• scheduled for implantation of deep brain stimulation device

• appropriate for awake surgery

• interest in participation

Exclusion Criteria:

Related Conditions & MeSH terms

• Ganglion Cysts
• Impulsive Behavior
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Neurological Disorders and Stroke (NINDS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity data	Extracellular voltage measurements (microelectrode recording) from single and multi-neuron activity in the basal ganglia.; Local field potentials from the same recording sites.	during treatment
Primary	Behavioral data	Interactions of patients with a video game task, including joystick button responses, points earned, and response times.	during treatment