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:
Massachusetts General Hospital
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
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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
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 February 25, 2015