NCT02786680

Brief Summary

A large body of evidence points to impairment in the decoding of emotional stimuli in Parkinson's disease (PD). These changes seem to be related to dysfunction of the mesocorticolimbic projections leading to dysfunction of the limbic cortico-subcortical loop that, throughout the basal ganglia, projects to limbic cortical regions such as the anterior cingulate cortex and the orbitofrontal cortex, which are known to be involved in emotional processing. Thus, presumably the occurrence of non-motor psychic symptoms and fluctuations in PD would also rely on the degeneration of this circuitry. Dopamine modulation of emotions has been frequently reported both in healthy subjects or PD patients, but the effect of subthalamic nucleus deep brain stimulation (STN-DBS) over mood symptoms is more controversial and there is still a paucity of data demonstrating its role in emotional processing. The objective of our study is to assess and compare the behavioral and electrophysiological effects of both dopamine and STN-DBS in PD during emotional processing. To do so, the Emotional Stroop task, a version of the classical Stroop test developed to investigate inhibition of emotional interference, will be performed by STN-DBS PD patients in four different treatment conditions while high resolution electroencephalographic cortical mapping is conducted. Using this approach, the investigators expect to better separate the mechanisms of psychic features related to either disease, dopaminergic treatment, subthalamic stimulation or the association of both, with the final aim of optimizing the clinical management of PD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 8, 2016

Last Update Submit

May 25, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Brain activity in electroencephalography in emotional conflict decision

    1 day

Study Arms (2)

stroop test in condition DBS off

EXPERIMENTAL

Condition 1 : On Med /Off Stim

Behavioral: stroop test in condition DBS on

stroop test in condition DBS on

ACTIVE COMPARATOR

Condition 2 : On Med /On Stim

Behavioral: stroop test in condition DBS off

Interventions

stroop test in condition DBS offBEHAVIORAL

Patients were evaluated in DBS Off

stroop test in condition DBS on
stroop test in condition DBS onBEHAVIORAL

Patients were evaluated in DBS On

stroop test in condition DBS off

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PD patients with STN-DBS
  • Healthy controls without neurologic pathology
  • Age between 18 and 70 years
  • Fluent in French
  • Signed informed consent
  • Patients covered by national health insurance

You may not qualify if:

  • Subjects concerned by articles L1121-5 to L1121-8 from Public Health Code.
  • Patients under psychotropic treatments without significant adverse event.
  • MATTIS \< 130
  • For Healthy controls MRI anormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Paul Krack, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

June 1, 2016

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share