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ON/OFF Stimulation and Impulsivity in Patients With Deep Brain Stimulators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01506206
Recruitment Status : Recruiting
First Posted : January 9, 2012
Last Update Posted : March 6, 2019
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital

Brief Summary:
The investigators propose a test of causality by examining a cohort of patients undergoing deep brain stimulation (DBS) within the ventral striatum. The investigators will examine behavior on and off stimulation across a range of tasks that index different forms of impulsivity. Patients will be studied in both the ON and OFF state - that is, they will be tested during active deep brain stimulation and 30 min to 1 hour after stimulation has been stopped (order of state will be counterbalanced across subjects). The investigators specific aim is to test the hypothesis that enhancing ventral striatal signaling (i.e. ON-state DBS) will cause more impulsive patterns of behavior across several impulsivity tasks. The investigators predict that ventral striatal DBS will increase stop-signal reaction time on the stop-signal task and commission errors on the Go/NoGo task, and increase delay aversion in a delay discounting paradigm.

Condition or disease
Obsessive Compulsive Disorder Major Depressive Disorder

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: ON/OFF Stimulation and Impulsivity in Patients With Deep Brain Stimulators
Study Start Date : February 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Patients with Deep Brain Stimulators
Patients with deep brain stimulation for either major depressive disorder (MDD) or obsessive compulsive disorder (OCD).
Patients with MDD or OCD
Patients with MDD or OCD who do not have a deep brain stimulator.

Primary Outcome Measures :
  1. Impulsive Action [ Time Frame: 2 hours ]
    As measured by the Go/No Go task

Secondary Outcome Measures :
  1. Impulsive Choice [ Time Frame: 2 hours ]
    As measured by delayed discounting task

Information from the National Library of Medicine

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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 Stimulators Patients with Major Depressive Disorder or Obsessive-Compulsive Disorder and no DBS

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

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 identifier (NCT number): NCT01506206

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Contact: Anna L Gilmour, BA 617-726-9281

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Darin D Dougherty, MD   
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Darin D Dougherty, MD Massachusetts General Hospital

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Responsible Party: Darin Dougherty, Associate Professor of Psychiatry, Massachusetts General Hospital Identifier: NCT01506206     History of Changes
Other Study ID Numbers: 2011P002546
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Keywords provided by Darin Dougherty, Massachusetts General Hospital:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Mood Disorders
Mental Disorders
Personality Disorders
Anxiety Disorders
Impulsive Behavior
Pathologic Processes