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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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