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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 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours for each visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours for each visit for reporting.

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

Deep Brain Stimulator (Device) Clinical Trial Eligibility Overview. Trial Name: NCT01590862 — N/A
Depression Research Study Groups: Deep Brain Stimulation On, Deep Brain Stimulation Off
Depression Clinical Trial 2023: Deep Brain Stimulator Highlights & Side Effects. Trial Name: NCT01590862 — N/A
Deep Brain Stimulator (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01590862 — N/A
Depression Patient Testimony for trial: Trial Name: NCT01590862 — N/A
~4 spots leftby Mar 2025