Imaging-Guided Transcranial Direct Current Stimulation (tDCS) in Major Depression

UCLA Clinical Research Study (IRB #17-000779)

We are recruiting participants for a research study conducted at UCLA. Research studies are voluntary and include only people who choose to take part, and who meet all of the eligibility criteria as determined by the study investigators.

Study Description


Transcranial direct current stimulation (tDCS) is a non-invasive method of neuromodulation that uses electrodes placed on the scalp to deliver a constant, low current. This study is being done to examine how tDCS affects the brain, and if brain changes are related to changes in mood. To see how tDCS affects brain signals, this study will use non-invasive MRI scans

To make sure that changes are because of tDCS and not for other reasons, people will be randomized (assigned by chance) to receive either active or non-active (sham) tDCS using standard or small (high definition, HD) electrodes. This means if you agree to participate, you might not receive active experimental tDCS. You will be told at the end of the study if this is the case. If you did not receive active tDCS during the research, you will be invited to receive the same number of active tDCS sessions after the study. You may decide or not decide to receive these additional active tDCS sessions after your research participation is complete.

We aim to enroll 60 patients who have serious depression who have not made any changes to current medication(s) for the past six weeks.

If you are eligible, your participation in the research may approximately one month. During this time, you will be required to make 13 separate visits to UCLA. Complete research study details can be found here.

This research study is being conducted with support from the UCLA Depression Grand Challenge and the National Institute of Mental Health (R61MH110526). We will give access to some of the data, including MRI images and most behavioral data, to the general public via the internet. We will make all of the data available to other investigators that have been approved by the study researchers. Your data will be coded and will NOT have your name on it or any other personally identifying information. 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.

Eligibility Requirements:

  • Currently diagnosed with depression.
  • Have not made any changes to current medications for the past 6 weeks.
  • Are between 18-55 years of age.
  • Are willing to receive several MRI scans.
  • Are able to comfortably wear an electrode cap.
  • Refrain from making any drastic hair changes over the course of the study to ensure that the electrode cap has a consistent fit throughout.
  • Live within driving distance to UCLA, and are able to come in daily (excluding weekends) for tDCS.

Process for determining eligibility:

  1. Initial eligibility will be determined by speaking with a study coordinator by phone, who will ask you questions about your medical history.
  2. If it appears that you may be eligible for the research study, we can schedule your consult visit to determine eligibility.
  3. Note – if you are currently taking benzodiazepines or sleeping pills, you must refrain from taking these for the duration of the study. If this is the case, we may also need a letter from your provider acknowledging your participation in the research study and plan to stop taking these medications for this period of time.
  4. If, after this initial Consult visit, you meet all eligibility criteria, a study coordinator will schedule all of your remaining visits as soon as our schedule allows.

The researchers may end your participation in the study for a number of reasons, such as if your safety and welfare are at risk, if you do not follow instructions or if you miss scheduled visits.

If you are interested in speaking with a study coordinator to find out if you are potentially eligible for the study:

Please email DGCNeurostimStudy@mednet.ucla.edu or call 424-402-9051 to speak to the Study Coordinator.

Research Study Details


If you are eligible, your participation in the research will last approximately one month. During this time you will be required to make 13 separate visits to UCLA.

  • To determine if you are potentially eligible to participate in the study, you must first speak with a study coordinator by phone, who will ask you questions about your medical history. Time: Approximately 15 minutes.
  • If it appears that you may be eligible for the research study, we can schedule your initial appointment (Consult visit) to determine eligibility. If you are currently taking benzodiazepines or sleeping pills, you will need to refrain from taking these for the duration of the study. If this is the case, we may also need a letter from your provider acknowledging your participation in the research study and plan to stop taking these medications for this period of time.
  1. Consult: the first visit to determine eligibility will include a psychiatric evaluation, detailed clinical mood evaluations, and you will receive a brain MRI scan. At the start of this visit you will be asked to sign the research consent form. The study doctors will need to review the results of these tests before deciding if you qualify for receiving tDCS. Time: Approximately 4 hours.
    • If you qualify, a study coordinator will schedule all of your remaining visits as soon as our schedule allows.
    • The remaining visits will occur approximately one week after your Consult visit and will be scheduled to occur on 12 consecutive days (excluding weekends).
    • These visits are based on the study physician, MRI scanner, and clinic availability, which are limited. Therefore, we do not have a lot of flexibility.
    • If you do not qualify, you will be notified by a study coordinator. As this is a research study, we have strict eligibility requirements, and exceptions cannot be made.
  2. Baseline Assessment: in your second visit you will complete some cognitive testing and mood evaluations, be prepared for tDCS administration, and receive a functional MRI scan lasting approximately 1 hour. During part of this scan, tDCS will be delivered. Time: Approximately 4 hours.
  3. Visits 3-6: in the next four consecutive visits, you will be prepared for tDCS administration, receive 20 minutes of tDCS in a private room, and complete mood assessments with study staff. Time: Approximately 1 hour.
  4. Visit 7: you will return for visit 7, during which you will be prepared for tDCS administration, receive 20 minutes of tDCS in a private room, complete mood assessments with study staff, and complete some cognitive tests of thinking and memory on a computer. Time: Approximately 3.5 hours.
  5. Visits 8-12: in the next five consecutive visits, you will be prepared for tDCS administration, receive 20 minutes of tDCS in a private room, and complete mood assessments with study staff. Time: Approximately 1 hour.
  6. Visit 13: you will return for visit 13, during which you will be prepared for tDCS administration and receive a functional MRI scan lasting approximately 1 hour. During part of this scan, tDCS will be delivered. You will complete mood assessments with study staff, and complete some cognitive tests of thinking and memory on a computer. Time: Approximately 3 hours.

In total, if you are determined to be eligible for the research study and you consent to participating in the research study - you will receive 3 separate MRI scans, receive tDCS on 12 consecutive visits (excluding weekends). Your participation in this study will be complete after approximately one month.

For this study, you will be randomly assigned to a group of participants that will either receive active tDCS or sham tDCS where one of two different electrode sizes and configurations will be used. Neither you or the experimenter will know if you are receiving active stimulation because this information will be pre- programmed into the tDCS device based on a randomization code. This means if you agree to participate, you might not receive active experimental tDCS. You will be told at the end of the study if this is the case. If you did not receive active tDCS during the research, you will be invited to receive the same number of active tDCS sessions after the study. You may decide or not decide to receive these additional active tDCS sessions after your research participation is complete.

Information about Transcranial Direct Current Stimulation (tDCS)


Below we include a summary of the medical and psychiatric uses of tDCS, potential adverse effects of tDCS, and major elements of the study protocol. Aspects of the study protocol will be implemented by UCLA research personnel, and not the patient’s psychiatrist or primary care physician.

tDCS uses in medicine and for treating depression:
  • tDCS is a non-invasive method of neuromodulation that uses electrodes placed on the scalp to deliver a constant, low current.
  • tDCS has been used in many clinical research studies across the world over the last few decades, and has been safely investigated in depression, anxiety, chronic pain, and stroke
  • tDCS has been used as an experimental treatment for major depression, with evidence of efficacy in the treatment of acute depressive disorder with moderate effect size1.
  • There is never a guarantee of response and currently no way to predict who might respond.
Additional Resources to read more about tDCS for the treatment of depression:
Risks associated with tDCS:
  • Potential risks and discomforts associated with tDCS include tingling, irritation, heating, or a light itching sensation under the electrodes. For many people, these sensations lessen or disappear soon after the start of stimulation, and are rarely reported as unpleasant.
  • If you become too uncomfortable during the tDCS procedure, you can inform the staff who will immediately stop the tDCS session on request. If you feel uncomfortable tingling after the first 30 seconds of tDCS during the MRI, you can use the emergency squeeze ball provided to alert the study staff to stop the scan and tDCS procedure immediately. If you feel heating under the tDCS electrodes at any time, you are asked to inform the staff immediately.
  • If your skin or scalp is currently irritated due to a pre-existing skin condition, treatment, or sensitivity, you must tell study staff at screening.
  • tDCS uses a low level of electrical current and is not associated with risk of seizure. Nevertheless, people with a history of seizures and/or seizure disorder are excluded from this study.
Treatment procedure:
  • Established safety precautions and parameters for tDCS will be strictly followed in this study.
  • For this study, you will be randomly assigned to a group of participants that will either receive active tDCS or sham tDCS where one of two different electrode sizes and configurations will be used. Neither you or the experimenter will know if you are receiving active stimulation because this information will be pre- programmed into the tDCS device based on a randomization code.
  • For both active and sham tDCS, rubber electrodes will be placed on your scalp using gel or paste to improve electrical impedance and secured with elastic straps or a cap. These electrodes will either be 7 cm x 5 cm in size (standard tDCS) or have 5 cm radius (HD tDCS).
  • We will need you to refrain from making any drastic hair changes over the course of the study, in order to ensure that the electrode cap has a consistent fit throughout.
  • During both active or sham tDCS, you might feel a mild tingling sensation under the electrodes that will lessen over about thirty (30) seconds. The mild intensity of the current delivered with tDCS can be compared to a flashlight powered by a 9-volt battery.
  • The tDCS sessions will last for twenty (20) minutes.
  • For the scans during which you will also receive tDCS, electrodes will be placed on your scalp and secured with elastic straps or a cap as above.
    • These electrodes will remain on your scalp throughout the MRI experiment.
    • The tDCS electrodes will be connected to a battery-driven constant direct current stimulator.
    • At a certain time during the scan, the tDCS device will deliver a mild electrical current to the electrodes.
    • You might feel a tingling sensation under the site of the electrodes that will diminish over time. This will feel the same whether you are receiving active or sham tDCS.
    • You will receive a 30-minute structural imaging scan at Visit 1, and a 1-hour functional imaging scan during which you will receive tDCS for 30 minutes or less at Visit 2 and Visit 13.
References
  1. Palm, U., Hasan, A., Strube, W., Padberg, F. tDCS for the treatment of depression: A comprehensive review. Eur Arch Psychiatry Clin Neurosci 2016; 266(8): 681-694.

Magnetic Resonance Imaging (MRI) Brain Scan


Participation in this research study requires four separate MRI scans. Each MRI scan lasts up to 2 hours

You cannot receive an MRI scan if:

  • You have metal implants that contraindicate MRI scanning.
  • You experience claustrophobia that would prevent you from staying inside a narrow, confined space for up to two hours at a time
  • If female, you are pregnant or there is a possibility that you may be pregnant.

If you have metal implants, we require specific manufacturing information of these implants in order to determine MRI safety. Without this information, you will not be eligible.

Unlike a CT scan, a MRI scan does not use radiation. A MRI is essentially a big magnet that functions like a camera. For our study we are specifically looking at the brain. By taking pictures of your brain, before and after your infusions, we may better understand how ketamine affects brain chemistry and function. The scans for our study can last up to 2 hours. During that 2 hours, you will be lying flat and completely still during each scan; you will either be asked to rest with your eyes open, to perform some computer tasks while viewing images on a screen, or watch movie clips. Your head and upper torso will be inside a large tube, and you will remain inside for the entire duration of the scan. In order to ensure you remain as comfortable as possible, the study team will check in with you in between each scan, and we will offer you an optional break nearly half way through the scan.

MRI

FAQ


  • Do you need a letter from my provider before I can schedule the first consult visit?
  • If you are currently taking benzodiazepines or sleeping pills, you must refrain from taking these for the duration of the study. If this is the case, we may also need a letter from your provider acknowledging your participation in the research study and plan to stop taking these medications for this period of time.

  • If I’ve been scheduled for my first consult visit, does that mean that I am eligible to receive tDCS as part of your research study?
  • No. We are only able to enroll people who have a certain history of depression and who can undergo brain scans and other procedures needed for the research. A study physician will review information collected during the first consult visit to determine if you are eligible to participate in the research study.

  • Why am I not eligible, and how can I receive tDCS if you have determined that I am not eligible?
  • We are only able to enroll people who have a certain history of depression and who can undergo brain scans and other procedures needed for the research. However, you may talk to your doctor about whether you might still be a candidate for tDCS for depression outside of this study.

  • Who are the Principal Investigators of this study?
  • This study is being conducted by Katherine Narr, PhD, Eliza Congdon, PhD, and other co-investigators from the Departments of Psychiatry and Neurology at the University of California, Los Angeles (UCLA).

  • Will I have access to the MRI data?
  • No, this information is only used for research purposes.

  • Are there any weekend visits?
  • No, all of our in-person visits are scheduled on the weekdays.

  • What if I have additional questions about my rights as a research subject?
  • Please call the UCLA Office Human Research Protection Program at (310) 825-5344.

  • I don’t live in Los Angeles, can I still be in the study?
  • Given the number of daily visits, you must live within driving distance of UCLA to enroll in the study.

  • Will I receive compensation and transportation reimbursements?
  • You may receive up to $650 for participation in the research study. You will receive $50 for each of the 13 research visits. You will receive payment after you have completed your first research visit (Visit 1), and the remaining payments after you have completed your final research visit (Visit 13). You will be reimbursed for parking at UCLA for each of the 13 research visits ($12 dollars each visit). Parking will be reimbursed at the time of each visit. Total payment over $600 will need to be reported to the IRS so your Social Security Number will be collected for this purpose only.

  • Will I need to take time off of work to participate in the study?
  • You will be able to return to work directly and resume your normal activities directly after research appointments.

  • Will I be able to reschedule any of the remaining study visits after I complete my baseline visit?
  • No, your study visits are scheduled in advance and confirmed with you before your baseline visit. These visits are scheduled based off of strict study protocol and our limited availability.

Directions & Parking Information


If you have completed pre-screening by phone with a Sleep Study coordinator, have given us a letter from your Psychiatrist or Primary Care Provider acknowledging your participation in the study, and have been scheduled for your initial visit to determine eligibility – below are directions for your first visit.

Depression Grand Challenge Study Location:

740 Westwood Plaza, Los Angeles, CA 90095

From the San Diego Freeway (405):

From the north, exit Wilshire East, or from the south, exit Wilshire at Westwood. Turn left on Westwood Blvd. and go straight past Le Conte Avenue (the street becomes Westwood Plaza as you enter the UCLA campus).

The closest parking lot to Semel is Lot JS on Stein Plaza. (Entrance for parking can be seen below.) Parking permits at Stein Plaza are available for $12. You will be given a parking voucher at the end of your visit that is valid at Lot JS.

Parking spot

Once you park at Stein Plaza, walk North on Westwood Plaza. The UCLA Medical Plaza is on your left; the Semel Institute/Department of Psychiatry is on your right. If you reach the cross street Charles E. Young Dr. S, you have gone too far.

semel

The Semel Institute is in the Center for Health Sciences (CHS) Building – unfortunately it has a fairly confusing layout. Please see the map (below) for CHS for directions once you’re inside Semel:

  • Enter the Semel Institute from the west entrance on Westwood Plaza. (As seen below)
  • semel entrance
  • Walk all the way to the end of the hallway, turn left, then take your first right.
  • Take the H Elevators up to the 2nd floor
  • Look for the waiting room with glass doors as soon as you exit the elevator. A coordinator will meet you here at your appointment time.

Contact Us:


Please email DGCNeurostimStudy@mednet.ucla.edu or call 424-402-9051 to speak to the Study Coordinator.

You may additionally contact the Principal Investigator, Dr. Katherine Narr at (310) 267-5119. For clinical concerns, you can contact Dr. Michael Boucher at (310) 794-2014.