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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Approach Avoidance Task
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
2,937 Previous Clinical Trials
13,198,990 Total Patients Enrolled
186 Trials studying Depression
29,636 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for me to participate in this medical study?
"For this research, 60 individuals aged 18-70 and currently experiencing aura will be selected. Furthermore, all participants must have had a deep brain stimulator implanted at least three months prior to the commencement of the study."
Answered by AI
What is the current enrolment for this research project?
"Affirmative. According to clinicaltrials.gov, this research project - initially posted on January 23rd 2021 - is actively seeking volunteers. 60 individuals are needed from two different medical centres."
Answered by AI
Are there still openings available for participants in this research?
"Confirmed. Clinicaltrials.gov confirms that this research is actively gathering participants, with the first posting dated January 23rd 2021 and last update on February 1st 2022. The study requires 60 individuals from 2 different sites for full enrollment."
Answered by AI
Is the age restriction for this experiment limited to persons aged 35 and above?
"This medical trial is recruiting participants aged 18 and over, but under the age of 70."
Answered by AI
Who else is applying?
What state do they live in?
Maine
Massachusetts
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
I’ve tried every drug on the market. I. My daughter has ocd. We need better treatments.
PatientReceived 1 prior treatment
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