CORRECT-BD


Brain Stimulation for Bipolar Depression

How it works

Bipolar Disorder is a common medical condition that can have many causes, such as life experiences, genetics, and changes in the way the body and brain function. Patients in a major depressive episode of bipolar disorder are often treated with medication; however, many patients do not fully respond to this medication treatment. We are doing this study to compare two different methods of brain stimulation: Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST).

MST is a treatment that involves stimulating certain areas of the brain with magnetic field pulses to induce a seizure. ECT uses electrical stimulation to stimulate the brain and induce a seizure. For both treatments, a seizure is induced while you are under general anesthesia. MST is an investigational treatment and has not yet been approved by Health Canada for clinical use outside of research studies like this one. ECT, on the other hand, has been in use for several decades and there is extensive research documenting its efficacy.

In this study, we will be collecting detailed information about your psychiatric history, depression symptoms, and a range of personality, cognitive, and lifestyle factors, while you receive either ECT or MST treatment for approximately 7 weeks. You also have the option of completing a brain scan before starting the treatment and after finishing the treatment.

Details

The purpose of this trial is to compare ECT and MST. Specifically we want to learn more about the effectiveness of these treatments for bipolar depression. We will also examine whether side effects, especially cognitive side effects (related to thinking), differ between the two treatments. Further, we will use brain scans before and after the treatment to understand how your brain reacts to each treatment.

Approximately half of the people enrolled in the study will receive ECT and half will receive MST treatment. The preparation process for treatments will be the same. Which group you will be assigned to will be decided randomly (by chance). This study is a double blind study. This means that neither you nor the people doing your assessments nor your regular health care providers will know what treatment you are receiving. This information can be found out at any time in case of emergency. Requests to reveal your assignment for your information or participation in other research studies will not be considered until this study has been completed and the results are known.

This is a Phase III study. A Phase III study is a study of an experimental drug or treatment which is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information to determine whether the experimental drug or treatment can be used safely.

Who is conducting this study?

The study is being conducted by researchers at the University of British Columbia (UBC), the Centre for Addictions and Mental Health (CAMH), and the Parkwood Institute in Ontario. The primary investigator in Vancouver is Dr. Fidel Vila-Rodriguez, director of the NINET lab at UBC Hospital.

Who can participate?

You may be able to participate if:

  • You are 18 years of age or more
  • You are able to provide informed consent and comply with study procedures.
  • You are an outpatient or inpatient
  • You have a score of ≥ 21 on the 24-item Hamilton Rating Scale for Depression (HRSD)
  • You are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
  • You are willing to staying on your current antidepressants throughout the treatment course
  • Are able to adhere to the intervention schedule
  • Meet the MST safety criteria (e.g., no metal in your head outside of your mouth, no prior history of seizures)
  • If considering, please inform us:

  • If you are pregnant, or thinking of becoming pregnant
  • Of all medications that you are taking, including herbal supplements and over the counter medication. If possible bring a list of medications, including how often you take them and the dosages.
  • If you have had any past injuries or surgeries, or other physical or mental health problems, including:
    • Aneurysm clips or coils
    • Stents in the neck or brain
    • Implanted stimulators
    • Cardiac pacemakers or implantable cardioverter defibrillator (ICD)
    • Metallic implants in your ears and eyes, (ex: dental implants, cochlear implants)
    • Hearing Aid
    • Shrapnel or bullet fragments in or near the head
    • Facial tattoos with metallic or magnetic-sensitive ink
    • Other metal devices or object implanted in or near the head
    • History of seizures and/or family history of seizures

    Commonly asked questions about the study:

    Q: Will my medical information be kept confidential?
    Your confidentiality will be respected. No information or records that disclose your identity will be published without consent, nor will any of your information or records that disclose your identity be removed or released without your consent, unless required by law.

    Q: How much will the treatment cost?
    A: Nothing. You will not be charged for the neurostimulation treatment (ECT or MST) or any tests that you undergo while in this study.

    Q: Are there benefits to participating in the study?
    A: Potential benefits to the subjects include careful medical monitoring, and improvement in their depressive symptoms during the study. However, no benefits from this study can be guaranteed. Information learned from this study may help other people undergoing ECT or MST for bipolar depression in the future. In general, we hope that the information learned from this study can be used in the future to benefit other people with bipolar disorder and related diseases.

    Q: How does MST work?
    A: In MST, high intensity magnetic field pulses are delivered through a magnetic coil. Rapidly alternating strong magnetic field pulses pass freely into a focused area of the brain and create a seizure. Stimulation is limited to a focused area in the brain and, therefore, has minimal effect on the surrounding brain tissue. This results in minimal cognitive side effects. MST produces an increase in cerebral blood flow to the regions of the brain responsible for depressive symptoms.

    Treatment Schedule

    You will be asked to complete up to 21 treatments (usually Monday, Wednesday, and Friday) for approximately 7 weeks. Please note that the duration of your visit to UBC will vary based on wait times in the clinic.

    Planning for Treatment Visits
    Because you will be receiving a general anaesthetic you cannot have anything to eat or drink after midnight the night before your treatment
    You MUST have an escort to take you home after each of your treatments. An escort may be a relative, friend, neighbour, case worker, etc. A taxi driver is not considered a suitable escort.

    Contact Information:

    For more details regarding the study, or to discuss enrolment, please contact us at 604-827-1361 or email ninet.lab@ubc.ca