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Procedure

fMRI-Guided rTMS for Depression

N/A

Waitlist Available

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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered before the first itbs, week 2, week 4 and after itbs treatment (week 6).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare the efficacy of fMRI guided TMS and conventional neuronavigated TMS on clinical response.

Secondary outcome measures

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 outcome measures

Incidence of Treatment-Emergent Adverse Events

Side Effects

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03337113

Discomfort during stimulation session.

100%

80%

60%

40%

20%

Study treatment Arm

WMT + rTMS

Sham WMT + rTMS

WMT + Sham rTMS

Sham WMT + Sham rTMS

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

~510

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor

18 Previous Clinical Trials

1,886 Total Patients Enrolled

4 Trials studying Depression

409 Patients Enrolled for Depression

Sara Tremblay, PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research

2 Previous Clinical Trials

278 Total Patients Enrolled

1 Trials studying Depression

256 Patients Enrolled for Depression

Lauri Tuominen, MD PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program currently accepting new participants?

"This medical trial, which was published on January 1st 2024 and last edited on November 21st 2023, is no longer enrolling participants. However, there are 1391 other clinical trials that are presently recruiting individuals for their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

Sara Tremblay 2024. "Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152705.

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