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Device
Deep Brain Stimulation for Neurological and Psychiatric Conditions
N/A
Recruiting
Led By Darin Dougherty, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Psychiatric 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 hours for each visit
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of electrical stimulation on approach/avoidance conflict in patients with epilepsy or depression/OCD.
Who is the study for?
This trial is for epilepsy patients with depth electrodes and adults with severe Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD) who have a deep brain stimulator implanted. Participants must be right-handed, have normal vision and hearing, and not suffer from bipolar disorder, psychosis, brain damage, cognitive impairments affecting consent ability, recent substance abuse, severe personality disorders or dementia.
What is being tested?
The study examines how electrical stimulation from Deep Brain Stimulators affects decision-making related to reward and aversion in patients. It involves performing tasks while undergoing EEG recordings for those with DBS implants for MDD/OCD and continuous recording in epilepsy monitoring unit subjects.
What are the potential side effects?
While the description does not specify side effects of DBS directly linked to this trial's procedures, common side effects of Deep Brain Stimulation can include headache, seizure during implantation procedure, temporary pain at the implant site(s), infection risk at the implant site(s), speech problems and unwanted mood changes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe mental health issues that would affect my participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 hours for each visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours for each visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Approach Avoidance Task
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Deep Brain Stimulation OnActive Control1 Intervention
We will assess Reward Motivation behavior with Deep Brain Stimulation on.
Group II: Deep Brain Stimulation OffActive Control1 Intervention
We will assess Reward Motivation behavior with Deep Brain Stimulation off.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,760 Total Patients Enrolled
194 Trials studying Depression
34,162 Patients Enrolled for Depression
Darin Dougherty, MD5.02 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are right-handed, have normal vision and hearing, and do not have a current diagnosis of major depressive disorder (MDD) or obsessive-compulsive disorder (OCD).You have a condition that prevents you from seeing the objects used in the study even with corrective measures, or have dementia or other cognitive impairments.I do not have severe mental health issues that would affect my participation.
Research Study Groups:
This trial has the following groups:- Group 1: Deep Brain Stimulation On
- Group 2: Deep Brain Stimulation Off
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT01590862 — N/A