Theta Burst Stimulation for Depression
(SyncT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Many people with depression do not get better with standard treatments like medication. One promising alternative is transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic pulses to stimulate specific brain regions. A particular pattern of TMS called continuous theta-burst stimulation (cTBS) is thought to reduce overactive brain activity in depression, but we do not yet fully understand how it works at the level of brain cells and connections.
This study aims to determine the biological mechanism by which cTBS changes brain activity in people with depression. Specifically, we are testing two competing ideas: (1) that cTBS works by weakening the connections between brain cells through a process called long-term depression (LTD), which is driven by a chemical messenger system called glutamate; or (2) that cTBS works by increasing the brain's natural "braking" system, driven by a different chemical messenger called GABA.
To test these ideas, participants with depression will receive cTBS along with one of four FDA-approved medications, or placebo, that either boost or block these chemical messenger systems. We will measure changes in brain activity using electroencephalography (EEG) recorded simultaneously with TMS. Specific patterns in the EEG signal, called TMS-evoked potentials (TEPs), act as a window into how different brain cell types are responding to stimulation.
Each participant will complete four study visits, each testing a different drug-TMS combination in random order. One group of participants will test drugs targeting the glutamate system (d-cycloserine and memantine). A second group will test drugs targeting the GABA system (lorazepam and baclofen). All drugs are given as a single oral dose and are commonly used in clinical practice.
Understanding exactly how cTBS works at a biological level could open the door to more effective, personalized TMS treatments.
Who Is on the Research Team?
Joshua C Brown, MD, PhD
Principal Investigator
Mclean Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cTBS paired with one of four FDA-approved medications or placebo across four study visits, testing different drug-TMS combinations.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Theta Burst Stimulation (cTBS)
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Active TMS and memantine
Active TMS and d-cycloserine
Active TMS and baclofen
Active TMS and lorazepam
Sham TMS and placebo drug
Active TMS and placebo drug
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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