Transcranial Magnetic Stimulation for Depression

Recruiting in Palo Alto (17 mi)

Overseen by Susan K Conroy, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Psychotropics

Disqualifiers: Suicidal, PTSD, OCD, Substance use, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main question it aims to answer are: Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? Researchers will compare brain scans and rumination scores before, during, and immediately after TMS. Participants will: Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but you must either be off psychotropic medications or on a stable dose for at least 6 weeks before starting the study and be willing to stay on that stable dose throughout the trial.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Depression?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is effective in treating major depression, especially in patients who have not responded to other treatments. Several studies, including randomized controlled trials, have demonstrated its efficacy in reducing symptoms of depression.

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Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS), including its repetitive form (rTMS), is generally considered safe for treating depression, though it can cause temporary side effects like headaches, local pain, and in rare cases, seizures. Safety studies have been conducted on both short-term and longer-term use, and expert recommendations exist to ensure its safe application.

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How is the treatment Transcranial Magnetic Stimulation (rTMS) for depression different from other treatments?

Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from medications that work through chemical changes. It is a non-invasive procedure, meaning it doesn't require surgery or medication, and is typically used when other treatments like antidepressants haven't worked.

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Eligibility Criteria

This trial is for adults with major depression that hasn't improved after at least one medication attempt. Participants will undergo brain scans and TMS treatments, and must be able to complete questionnaires and a computer task.

Inclusion Criteria

Ability to safely receive MRI

I am able to understand and agree to the study's requirements.

I am not on psychotropic drugs or have been on a stable dose for 6 weeks.

Exclusion Criteria

I have a history of seizures or take medication that could lower my seizure threshold.

Actively/imminently suicidal, Quick Inventory of Depressive Symptomatology (QIDS) item 12 score >2

Current depressive episode duration > 5 years

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment

Participants undergo self-report and clinician-administered assessments, as well as a baseline fMRI scan

1 week

1 visit (in-person or virtual)

Treatment

Participants receive 20 daily sessions of rTMS to the VMPFC along with weekly assessments

4 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a telephone contact for adverse event assessment

2 weeks

1 contact (telephone)

Participant Groups

The study tests if Transcranial Magnetic Stimulation (TMS) targeting the VMPFC part of the brain can reduce rumination in treatment-resistant depression. It measures changes in brain activity and rumination through fMRI scans before, during, and after TMS sessions.

Group I: Active TMS Experimental Treatment 1 Intervention

All participants will receive active TMS to the VMPFC for 20 sessions

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Goodman Hall Neuroscience Center Indianapolis, IN

Who Is Running the Clinical Trial?

Indiana University Lead Sponsor

National Center for Advancing Translational Sciences (NCATS) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression. [2022] Effectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.

2. England pubmed.ncbi.nlm.nih.gov

A happiness magnet? Reviewing the evidence for repetitive transcranial magnetic stimulation in major depressive disorder. [2021] First, to conduct a historical review of the evidence for repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder and determine a clinical algorithm. Second, to identify opportunities for research.

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of mood disorder: a review and comparison with electroconvulsive therapy. [2017] To review repetitive transcranial magnetic stimulation (rTMS) as a mode of therapy for depression.

4. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. [2022] The aim of this preliminary report is to demonstrate the efficacy of rapid transcranial magnetic stimulation (rTMS) in the treatment of relapsed major depressive disorder (MDD) patients.

5. Canada pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022] To date, several randomized controlled trials (RCTs) have shown the efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression.

6. United States pubmed.ncbi.nlm.nih.gov

Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. [2022] To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD).

7. England pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021] In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).

8. United States pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019] The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.

9. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019] Repetitive transcranial magnetic stimulation (rTMS) is increasingly being utilised as a treatment option for depression, and with this comes a need for a practical review of safety issues intended for clinicians. This article provides an overview of the current literature regarding safety issues with rTMS for depression, and provides recommendations for clinical practice.

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. [2020] Major depressive disorder is often resistant to antidepressant treatment. Repetitive transcranial magnetic stimulation (rTMS) has been used in treatment-resistant depression (TRD). Known adverse events of rTMS include transient headache, local pain, syncope, seizure induction, and hypomania induction. This report outlines a patient with TRD who unexpectedly improved following a seizure during the course of rTMS, which has never been reported.

11. United States pubmed.ncbi.nlm.nih.gov

A practical guide to the use of repetitive transcranial magnetic stimulation in the treatment of depression. [2022] Repetitive transcranial magnetic stimulation (rTMS) is currently emerging as a new treatment for patients with mood disorders. Research into the use of rTMS for the treatment of patients with depression has been conducted now for a period of greater than 15 years and a considerable body of knowledge has accumulated informing its use.

12. Netherlands pubmed.ncbi.nlm.nih.gov

An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. [2021] Repetitive transcranial magnetic stimulation (rTMS) is an increasingly used treatment for patients with depression. The use of rTMS in depression is supported by over 20 years of clinical trials. There has been a significant increase in knowledge around the use of rTMS in recent years.

13. England pubmed.ncbi.nlm.nih.gov

Is it time to introduce repetitive transcranial magnetic stimulation into standard clinical practice for the treatment of depressive disorders? [2017] To examine issues relating to the potential introduction of repetitive transcranial magnetic stimulation (rTMS) into clinical practice as a treatment for depression.