NCT02231645

Brief Summary

The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS) can affect moral and economic decisions in patients with Parkinson's disease (PD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

September 1, 2014

Last Update Submit

October 28, 2020

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDeep brain stimulationSubthalamic nucleusdecision-makingcognitionbehavior

Outcome Measures

Primary Outcomes (1)

  • Reaction times and responses recorded at the moral task

    For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)

Secondary Outcomes (1)

  • Reaction times and responses recorded at the economics task

    For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)

Study Arms (2)

STN DBS group

EXPERIMENTAL

Experimental protocol is executed in PD patients with STN DBS implant in STN DBS ON and OFF conditions

Device: STN DBS

Control group

NO INTERVENTION

Experimental protocol is executed in PD patients without STN DBS implant twice without experimental variable manipulation.

Interventions

STN DBSDEVICE

The DBS device is turned on and off by the physician.

STN DBS group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease
  • For experimental group: STN DBS implant occurred no less than 6 months before and with optimal stimulation parameters

You may not qualify if:

  • Cognitive, behavioural and psychiatric symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseBehavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alberto Priori, MD, PhD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 4, 2014

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

October 29, 2020

Record last verified: 2020-10