Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01590862
First received: April 27, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention
Obsessive Compulsive Disorder
Major Depressive Disorder
Device: Medtronic IPG Neurostimulator

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Effort Expenditure for Rewards Task (EEfRT) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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:
  • Reward learning (clock task) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation Effects on Reward Motivation
We will assess changes in Reward Motivation behavior with Deep Brain Stimulation on and off.
Device: Medtronic IPG Neurostimulator
We will assess changes in reward motivation behavior with DBS system on and off

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590862

Contacts
Contact: Alexandra M Rodman, BS 617-726-9281 arodman@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: Alexandra M Rodman, BA    617-726-9281    arodman@partners.org   
Principal Investigator: Darin D Daugherty, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Darin Dougherty, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01590862     History of Changes
Other Study ID Numbers: 2011P002821
Study First Received: April 27, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Obesessive Compulsive Disorder and Major Depressive Disorder

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

ClinicalTrials.gov processed this record on November 27, 2014