ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2015 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: October 27, 2015
Last verified: October 2015
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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 |
|---|
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Obsessive Compulsive Disorder Major Depressive Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators |
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: | 60 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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: Anna L Gilmour, BA 617-726-9281 agilmour@partners.org | |
| Principal Investigator: Darin D Daugherty, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
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 |
| Study First Received: | April 27, 2012 |
| Last Updated: | October 27, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 Compulsive Behavior |
Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Personality Disorders Anxiety Disorders Impulsive Behavior |
ClinicalTrials.gov processed this record on September 23, 2016