ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators

NCT01590862 | Completed FDA Device

• 1 other identifier: 2011P002821
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

We propose to study approach/avoidance behavior as measured by the Approach Avoidance task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of VC/VS electrical stimulation on approach-avoidance conflict in 20 adult patients who have undergone DBS implantation for severe MDD and/or OCD. There are 100-200 patients in the world with DBS electrodes in the VC/VS, and our research team cares for more than any other institution. Both participant groups will be assessed with respect to reward-aversion decision conflict using the task. The task will be performed with concurrent EEG recordings in DBS patients, and with continuous recording through our invasive neurophysiology rig in EMU subjects.

Conditions

Obsessive Compulsive Disorder; Epilepsy; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Approach Avoidance Task

  The Approach Avoidance task is a computer task that assesses approach avoidance behavior. 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.

  Up to 8 hours for each visit

Study Arms (2)

Deep Brain Stimulation On

ACTIVE COMPARATOR

We will assess Reward Motivation behavior with Deep Brain Stimulation on.

Device: Deep Brain Stimulator

Deep Brain Stimulation Off

NO INTERVENTION

We will assess Reward Motivation behavior with Deep Brain Stimulation off.

Interventions

Deep Brain Stimulator DEVICE

Medtronic Deep Brain Stimulation device turned on and off

Deep Brain Stimulation On

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Deep brain stimulator implantation performed at least three months prior to study

You may not qualify if:

• Subjects unable to visualize stimulus objects with correction
• Dementia or other known cognitive deficit
• Psychiatric Patients:
• Right-handed (as determined by the Handedness Inventory; Oldfield,1971)
• Normal or corrected-to normal vision and hearing
• Current diagnosis of MDD or OCD
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Depressive Disorder, Major; Epilepsy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Darin Dougherty, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 3, 2012
• Study Start: January 23, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (2)