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Procedure

fMRI-Guided rTMS for Depression

N/A
Recruiting
Led By Sara Tremblay, PhD
Research Sponsored by The Royal Ottawa Mental Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International Neuropsychiatric Interview)
Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode
Must not have
Have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction)
Unwilling to maintain current antidepressant regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered before the first itbs, week 2, week 4 and after itbs treatment (week 6).
Awards & highlights
No Placebo-Only Group

Summary

This trial explores whether a personalized approach to a brain stimulation treatment can improve outcomes for people with major depressive disorder.

Who is the study for?
This trial is for adults with major depression who haven't improved after trying at least one antidepressant. They must be over 18, speak English, and have moderate symptoms without psychotic features. People can't join if they have bipolar disorder, recent substance abuse (except mild cannabis or alcohol), are pregnant/breastfeeding, or have conditions like epilepsy that make TMS risky.
What is being tested?
The study tests whether using fMRI to guide iTBS treatment improves outcomes in depression compared to standard iTBS targeting methods. Participants will undergo an MRI scan followed by a 6-week iTBS treatment, with their response measured by changes in depressive symptom scores.
What are the potential side effects?
iTBS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. The MRI procedure might lead to feelings of claustrophobia or discomfort lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression without psychosis.
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My depression hasn't improved after trying at least one antidepressant.
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My mental state score is above 24, and I am over 65.
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My depression symptoms are moderate, as shown by my test scores.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major uncontrolled illnesses like diabetes or kidney problems.
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I am not willing to keep my current antidepressant treatment.
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I do not have epilepsy, seizures, metallic head implants, or a pacemaker.
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I have been diagnosed with bipolar disorder (I or II).
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I take more than 1 mg of lorazepam or its equivalent daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered before the first itbs, week 2, week 4 and after itbs treatment (week 6).
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered before the first itbs, week 2, week 4 and after itbs treatment (week 6). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare the efficacy of fMRI guided TMS and conventional neuronavigated TMS on clinical response.
Secondary study objectives
Change in motion heart rate variability as measured with Empatica EmbracePlus Smartwatch
Change in motion intensity (based on number of steps and total activity) as measured with Empatica EmbracePlus Smartwatch
Change in perceived stress as measures with Perceived stress scale (PSS)
+12 more
Other study objectives
Incidence of Treatment-Emergent Adverse Events
Side Effects

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03337113
8%
Discomfort during stimulation session.
100%
80%
60%
40%
20%
0%
Study treatment Arm
WMT + rTMS
Sham WMT + rTMS
WMT + Sham rTMS
Sham WMT + Sham rTMS

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: fMRI guided iTBS targettingExperimental Treatment1 Intervention
The target selected is based on functional connectivity determined from the MRI scan.
Group II: Neuronavigation guided iTBS targettingActive Control1 Intervention
A technique for treatment location targeting, based on structural images of the brain using standard coordinates.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive Transcranial Magnetic Stimulation
2017
Completed Phase 2
~540

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
19 Previous Clinical Trials
1,890 Total Patients Enrolled
Sara Tremblay, PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research
3 Previous Clinical Trials
288 Total Patients Enrolled
Lauri Tuominen, MD PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research
~140 spots leftby Oct 2027
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