Clinical Trial 38736

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Los Angeles, CA 90095


Study Summary:

Volunteers with Depression needed for tDCS Study: If you have been diagnosed with depression, are unmedicated or on stable antidepressant medication, are between 18-55 years old, and are able to receive a brain scan - you may be eligible to participate in a depression research study using neurostimulation. 

  • This study uses transcranial direct current stimulation (tDCS), a non-invasive neuromodulation therapy, which is sometimes shown to reduce depressive symptoms. 
  • This study involves 13 visits to our laboratory over two-to-three weeks.
  • Study procedures include 30-minute tDCS sessions delivered at each visit.
  • The research also includes a brain scan at three different time points, before and after receiving tDCS. 
  • Participants can earn up to $650 for completing all appointments. 

 

Protocol ID: IRB#17-000779    UCLA IRB Approved   Approval Date: 5/24/2018   Through: 5/23/2019   Committee: Medical IRB 3

 

This research study will examine how transcranial direct current stimulation (or tDCS) might work to reduce depressive symptoms. Transcranial  direct  current  stimulation  (or  tDCS)  is  a  type  of  neuromodulation  that  uses  electrodes placed on the scalp to deliver a constant, low current over a period of time. Prior research has shown that  tDCS  may  be  helpful  for  reducing  depressive  symptoms  in  some,  but  not  all,  patients  with depression.  Unfortunately,  we  cannot  know  if  any  particular  patient  with  depression  will  benefit  with tDCS treatment. To improve our understanding of how tDCS might work for reducing depressive symptoms, this study is  designed  to  examine  how  tDCS  influences  brain  signals  measured  with  non-invasive  MRI  scans. To make sure the changes in brain signal are related to tDCS and not to other factors, one third of the participants enrolled in  this study  will be randomized to receive sham or non-active tDCS treatment. This  means  that  if  you  enroll  in  this  study,  you  will  not  know  until  after  the  study  is  complete  if  you received  active  tDCS  treatment.  If  you  do  not  receive  active  treatment  during  the  study,  you  may request to receive the same number of active tDCS sessions after the study. 

 

Participation starts with a phone screening, followed by visit #1 at UCLA, which lasts about 4 hours and will include a clinical evaluation, health history, mood assessments, and a short 30-minute MRI scan that will be used to help determine where to best place the electrodes on your scalp for tDCS. The study doctors will  need  to  review  the  results  of  these  interviews  before  confirming  if  you  qualify  for  research participation. If eligibility is confirmed, you will then be scheduled for a 12 additional study visits that will start a few days after your initial visit. On the second visit,  you will receive another MRI scan with tDCS administered at the same time.  This scan will last approximately 1 hour.  During  this  appointment,  you  will  again  be  asked  about  your  mood  and  will  complete some  brief  computerized  tests  of  cognition  and  memory.  The  total  appointment  time  will  last approximately 3-4 hours. Over  the  next  10 consecutive  days  (excluding weekends),  you  will  return  to  UCLA  for  10  additional visits.  During these visits you will receive tDCS in a private room for 30-minutes and complete brief mood assessments. The total appointment time for these 10 visits will be approximately 1-hour.  For the  7th visit,  the  appointment  will  also  include  tests  of  cognition and memory  and  last  approximately 3.5-hours. For  the  final  (13th)  visit,  you  will again  receive  an  MRI  scan  with  tDCS administered at the same time,  complete a number of surveys, and complete brief computerized tests of cognition and memory.  During this visit you will also receive compensation for your participation in the study. 

 

This research study is being conducted with support from the UCLA Depression Grand Challenge and the National Institute of Mental Health Human Connectome Project, which aims to acquire and share data about the structural and functional connectivity underlying human brain function as well as disease. For this reason, we will give access to some of the data, including MR images and most behavioral data, to the general public via the internet or other investigators that have been approved by the study researchers. Your data will be coded and will not have your name on it. Letting us use and share your data is voluntary, however, you must be willing to share your data in this way in order to participate in this study. If you are not willing, you cannot participate in this research study.


Qualifications:

 

  • Patients must be diagnosed with depression and currently experiencing moderate-to-severe depression.

 

  • Patients must be able to undergo MRI scanning. 
  • This means that patients cannot have any metal implants, such as a pacemaker, aneurysm clip, non-removable piercings, or permanent retainers. 
  • This means that patients cannot experience claustrophobia. MRI scans require being inside of a small space for up to an hour at a time.
  • This means that women who are pregnant or at risk for becoming pregnant are not eligible. 
  • Patients currently taking benzodiazepines or decongestants must refrain from taking them for the duration of the trial
  • Patients must be able to have an electrode cap comfortably placed on their head, in the same position, at each visit. This means that your hair must allow you to comfortably wear a standard baseball cap, and you must agree to refrain from making any drastic hair changes for the duration of the study.  
  • Patients must live in Los Angeles.
  • Patients who are currently receiving antidepressant therapy must be stable on their medications for at least 6 weeks prior to study participation
  • Patients cannot be receiving any form of psychotherapy 
  • Patients must not have received any neuromodulation treatment (e.g., ECT, rTMS, DBS, VNS, or tDCS) within the last 3 months
  • Patients must not have neurological conditions or major illnesses, including seizure disorder

 


Qualified Participants May Receive:

  • Participants can earn up to $650 for completing all appointments. 


Study is Available At:

University of California Los Angeles (UCLA)
760 Westwood Plaza
Los Angeles, CA 90095
View Clinic Location
 

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.