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ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators

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ClinicalTrials.gov Identifier: NCT01590862
Recruitment Status : Recruiting
First Posted : May 3, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital

Study Description
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Brief Summary:
The primary aim of this study is to test the effects of excitation of ventral striatal circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators predict that stimulation will increase subject willingness to expend effort for rewards and facilitate motivation for reward learning. The investigators further predict that individual differences in the effects of DBS on reward motivation as will be associated with effects of DBS treatment on anhedonic symptoms.

Condition or disease
Obsessive Compulsive Disorder Major Depressive Disorder

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Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators
Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Groups and Cohorts
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Group/Cohort
Deep Brain Stimulation Effects on Reward Motivation
We will assess changes in Reward Motivation behavior with Deep Brain Stimulation on and off.
Patients with MDD or OCD
Patients with MDD or OCD who do not have a deep brain stimulator.


Outcome Measures
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Primary Outcome Measures :
  1. Effort Expenditure for Rewards Task (EEfRT) [ Time Frame: 2 hours ]
    The EEfRT is a multi-trial computer-based task that assess an individual's willingness to expend effort for the chance to earn monetary rewards. We will assess whether stimulation of the Ventral Capsule/Ventral Striatum has an effect on behavior by executing this task with the DBS system on and off.


Secondary Outcome Measures :
  1. Reward learning (clock task) [ Time Frame: 2 hours ]
    This task is an additional reward task that assesses reward learning. We will assess whether stimulation of the Ventral Capsule/Ventral Striatum has an effect on behavior by executing this task with the DBS system on and off.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Deep Brain Stimulation AND Patients with Major Depressive Disorder or Obsessive-Compulsive Disorder and no DBS
Criteria

DBS Patients:

Inclusion Criteria:

  • Deep brain stimulator implantation performed at least three months prior to study

Exclusion Criteria:

  • Subjects unable to visualize stimulus objects with correction
  • Dementia or other known cognitive deficit

Psychiatric Patients:

Inclusion Criteria:

  • Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
  • Normal or corrected-to normal vision and hearing
  • Current diagnosis of MDD or OCD

Exclusion Criteria for Patients:

  • Clinical history of bipolar disorder
  • Current or past psychotic disorder
  • Gross structural brain damage
  • Cognitive impairment that would affect a participant's ability to give informed consent
  • Current substance abuse, or abuse within the past 3 months
  • Clinical history of severe personality disorder
  • Imminent risk of suicide or an inability to control suicide attempts
  • Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590862


Contacts
Contact: Aishwarya Gosai, BA 617-724-0244 agosai@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Darin D Dougherty, MD       ddougherty@partners.org   
Principal Investigator: Darin D Dougherty, MD         
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Anna L Gilmour, BA    617-726-9281    agilmour@partners.org   
Principal Investigator: Darin D Daugherty, MD         
Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Responsible Party: Darin Dougherty, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01590862     History of Changes
Other Study ID Numbers: 2011P002821
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Darin Dougherty, Massachusetts General Hospital:
Obesessive Compulsive Disorder
Major Depressive Disorder
Deep Brain Stimulation

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
 Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Personality Disorders
Anxiety Disorders