Transcranial Magnetic Stimulation for Depression

Overseen By Joan Camprodon, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: TMS

Disqualifiers: Schizophrenia, Dementia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Transcranial Magnetic Stimulation (TMS) affects the brains of people with unipolar depression. TMS uses magnetic fields to stimulate nerve cells in the brain, aiming to improve depression symptoms. The study is observational, so researchers will watch and record how TMS affects participants without altering their treatment. People diagnosed with unipolar depression and already using TMS as part of their psychiatric care might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to understanding TMS's impact on depression.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Transcranial Magnetic Stimulation is safe for patients with unipolar depression?

Research has shown that Transcranial Magnetic Stimulation (TMS) is a safe treatment for people with depression. Studies have found that TMS is generally well-tolerated and has safety results similar to those of antidepressant medications. One study found TMS as effective as the medication venlafaxine for individuals whose depression did not improve with other treatments, without causing significant side effects.

Another study found TMS safe for both unipolar and bipolar depression, with no major safety concerns. Additionally, a large analysis showed that using TMS alongside antidepressants can improve symptoms without adding extra safety risks.

Overall, TMS has a strong safety record, making it a good option for those considering this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive option for treating unipolar depression by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional antidepressants, which often take weeks to become effective and can have various side effects, TMS provides a quicker onset of relief with minimal side effects. Researchers are excited about TMS because it targets specific areas of the brain involved in mood regulation, potentially offering a more precise and personalized treatment option for patients who haven't responded to other therapies.

What evidence suggests that Transcranial Magnetic Stimulation is effective for depression?

Transcranial Magnetic Stimulation (TMS), which participants in this trial will receive, has proven effective for treating unipolar depression. In one study, about 36% of patients who received TMS experienced complete symptom relief, compared to only about 8% in a group that did not receive TMS. Another retrospective study found that 62% of patients responded positively to TMS, and 31% experienced full remission of their depression. TMS is considered safe, has strong antidepressant effects, and causes few side effects, making it a promising treatment option for those with depression. ^{2 5 6 7 8}

Who Is on the Research Team?

Joan Camprodon, MD, MPH, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-80 with a diagnosis of depression who need Transcranial Magnetic Stimulation (TMS) as part of their psychiatric care. It's not suitable for those with MRI contraindications, other primary mental health conditions like schizophrenia, active substance abuse in the past 3 months, or severe medical illnesses.

Inclusion Criteria

I have been diagnosed with depression.

I need TMS treatment for my mental health condition.

Exclusion Criteria

Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia

Substance use disorder (abuse or dependence) with active use within the last 3 months

MRI contraindications as determined by MGH department of radiology.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Magnetic Stimulation (TMS) and are scanned using fcMRI before and after the treatment

6 weeks

Follow-up

Participants are monitored for changes in functional connectivity and clinical measures for depression severity and memory

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study observes how TMS affects the brain in patients with unipolar depression. This non-invasive treatment uses magnetic fields to stimulate nerve cells in the brain and is being studied using neuroimaging techniques.

How Is the Trial Designed?

Group I: Unipolar Depression Experimental Treatment 1 Intervention

Patients diagnosed with unipolar depression.

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33074144/

The efficacy of repetitive transcranial magnetic stimulation ... rTMS seems effective in the treatment of bipolar depression, but dedicated and adequately powered RCTs are needed in order to firmly conclude that rTMS should ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10375664/

Efficacy of repetitive transcranial magnetic stimulation ... Data on remission rates were available from 9 studies. The overall remission rate was 35.71% (120/336) in the active rTMS group and 8.37% (18/ ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S240584402403319X

Real-world retrospective study of repetitive transcranial ... These results were numerically superior to the 62% response and 31% remission rates observed for unipolar depression. In general, the treatment ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667174325001727

Efficacy, effectiveness and safety of transcranial magnetic ... TMS is efficacious and safe in BDep, with response and remission rates on par with unipolar depression. High and low frequency protocols on left ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/210744

Daily Left Prefrontal Transcranial Magnetic Stimulation ... The results of this study suggest that prefrontal rTMS is a monotherapy with few adverse effects and significant antidepressant effects for unipolar depressed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5925584/

Meta-analysis of the Efficacy and Safety of Repetitive ... After Meta-analysis, we found that treatment combined rTMS with antidepressants improves depressive symptoms in patients with depression.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... The relapse prevention success rate at 24 weeks in the rTMS monotherapy group was approximately 85%, whereas prior literature indicates that the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25192980/

the results from a large multicenter French RCT Low frequency rTMS appears to be as effective as venlafaxine and as effective as the combination of both treatments for TRD.