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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01506206
First received: January 5, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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
Obesessive 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: 30
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Deep Brain Stimulators

  Show Detailed Description

  Eligibility

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

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: NCT01506206

Contacts
Contact: Alexandra M Rodman, BA 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   
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Deep Brain Stimulation
Impulsivity

Additional relevant MeSH terms:
Depressive Disorder
Depression
Impulsive Behavior
Depressive Disorder, Major
Compulsive Personality Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Personality Disorders

ClinicalTrials.gov processed this record on August 20, 2014