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

This study is currently recruiting participants.
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
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 April 17, 2014