Study title: A randomized, placebo-controlled, crossover trial of d-cycloserine repetitive transcranial magnetic stimulation plasticity enhancement in the healthy motor system

Principle Investigator: Alexander McGirr, MD MSc FRCPC

Description

We are conducting a study in healthy individuals to test a strategy of enhancing the effects of a non-invasive brain stimulation technique (repetitive transcranial magnetic stimulation or rTMS). This is an important first step towards our long-term goal of improving the benefits patients receive from this Health Canada approved treatment for depression. Specifically, we are looking for healthy individuals who are willing to come to the laboratory four times, to receive brain stimulation while we record muscle activity in a small muscle of the hand, and to take a low dose of an antibiotic (d-cycloserine) that is being repurposed for its ability to enhance adaptive changes in the brain. 

The study involves four visits because we are asking participants to complete two sessions with 2 visits each. Specifically, we are asking participants to 1) come back the following morning after their brain stimulation session for a brief visit, and 2) we are asking participants to do a session of brain stimulation after taking a capsule with the real medication and after taking a capsule containing a placebo, in random order. These two sessions will be separated by at least a week, and neither you nor the researchers will know in which order you received the placebo or the real medication. This is a way of ensuring that any effects we see are truly related to the medication.

Though ultimately our goal is to conduct a treatment trial in depression, we are not specifically looking for people with depression or a history of depression for this study. The goal of this study is first to test the strategy before moving to brain targets involved in depression. We do not expect the effects of the current study to be in any way beneficial in depression.

Inclusion criteria

• Healthy individuals without chronic medical conditions
• Aged 18-60

Exclusion criteria

• Pregnancy
• Lactation (breastfeeding)
• Epilepsy or history of seizures
• Previous Stroke
• Current Renal Disease
• Current Liver Disease
• Current Alcohol Use Disorder or other form of addiction
• Inability to refrain from alcohol use for 24 hours prior to each session and following each session.
• Allergy to antibiotics
• Use of isoniazid or ethionamide (tuberculosis medications that interact with d-cycloserine)
• Current psychiatric concerns that would interfere with study visits (for example, depression or anxiety severe enough that would make attending visits or staying until the end of the visit challenging)
• History of bipolar disorder
• Family history of bipolar disorder

Contact

Contact information for this study is forthcoming. If you are interested in participating please email n3research [at] ucalgary.ca.

Study title: A Randomized Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in Acute Bipolar Depression

Principle Investigator: Alexander McGirr, MD PhD FRCPC

Description:

Can we use brain stimulation to help with depressive symptoms in bipolar disorder?  This study will examine the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving depressing symptoms in bipolar disorder. rTMS is a treatment that involves stimulating a certain area of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of depression. The device used in this study has been approved by Health Canada for therapeutic use.

We are recruiting volunteers with Bipolar Disorder who are currently depressed between the ages of 18-70. Eligible participants will be randomized, like the flip of a coin, to receive either active rTMS treatment that involves brain stimulation, or sham-rTMS (like a placebo) that does not involve brain stimulation. rTMS treatment involves daily session on weekdays over a 4 week period for a total of 20 sessions. Neither the participant nor the researchers will know if active or sham rTMS was administered, however at the end of the study, all participants will be offered an additional 4 weeks of active rTMS treatment.

Our focus is on clinical improvement in depressive symptoms, though we will also look at other aspects. Participants will have an MRI before and after rTMS to measure changes in functional brain connectivity, and neurocognitive testing will assess any changes in cognition.

Participants will be reimbursed for travel costs.

Inclusion Criteria:

• Aged 18-70
• Have a diagnosis of Bipolar Disorder, and are taking medications for Bipolar Disorder.
• Currently experiencing a depressive episode

Exclusion criteria: (including but not limited to)

• Have an alcohol or substance use disorder within the last 3 months
• Suicidal
• Pregnant, breast feeding, or plan to become pregnant
• History of epilepsy
• Metal objects within or near the head that cannot be removed (not including dental hardware)

Contact

If you are interested in participating in this study, please contact Jaeden Cole (Study Coordinator) jaeden.cole1@ucalgary.ca, phone (403) 210- 6504