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Parkinson's DiseaseNCT02319694

Intraoperative Analysis of Reward and Impulsivity in the Basal Ganglia

An observational study of Parkinson's Disease, run by Duke University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Parkinson's Disease
How many people
36 participants
Where
No sites listed yet
Study dates
Jul 2013to 27 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants are patients scheduled to be implanted with Deep Brain Stimulation devices for treatment of Parkinson's Disease or Essential Tremor.

Who may be able to join

  • scheduled for implantation of deep brain stimulation device
  • appropriate for awake surgery
  • interest in participation

Who cannot join

  • none

About this study

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.

Read the detailed 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.

Keywords
Basal Ganglia, Behavior, Behavioral, Brain, Cognitive, Computer Simulation, Cues, Data, Deep Brain Stimulation, Disease
Medical subject headings
Parkinson Disease, Behavior, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: during treatment

  2. Behavioral data

    Interactions of patients with a video game task, including joystick button responses, points earned, and response times.

    Measured: during treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2014 (estimated)
  2. Study startJul 2013
  3. Primary completion27 Feb 2017
  4. Study completion27 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02319694
Sponsor's protocol ID
Pro00045557
Other IDs
R21NS084176
Status last verified
May 2018
First submitted
15 Dec 2014
Last updated
1 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain activity data (time frame: during treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.

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