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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Massachusetts General Hospital
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
First received: January 5, 2012
Last updated: October 23, 2015
Last verified: October 2015
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.

Obsessive Compulsive Disorder
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: ON/OFF Stimulation and Impulsivity in Patients With Deep Brain Stimulators

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Impulsive Action [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    As measured by the Go/No Go task

Secondary Outcome Measures:
  • Impulsive Choice [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    As measured by delayed discounting task

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: NCT01506206

Contact: Anna L Gilmour, BA 617-726-9281 agilmour@partners.org

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Darin D Dougherty, MD       ddougherty@partners.org   
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Darin D Dougherty, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Darin Dougherty, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01506206     History of Changes
Other Study ID Numbers: 2011P002546
Study First Received: January 5, 2012
Last Updated: October 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Deep Brain Stimulation

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

ClinicalTrials.gov processed this record on November 27, 2015