TMS vs ECT for Depression

Overseen By Austin R Messner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Austin Messner

Disqualifiers: Seizures, Neurological disorder, 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: 14

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for individuals with treatment-resistant depression who have already found some relief from electroconvulsive therapy (ECT). It examines how well transcranial magnetic stimulation (TMS), a noninvasive brain stimulation therapy, maintains depression remission compared to ongoing ECT. Participants will choose between continuing their care with TMS or receiving more ECT sessions after their initial ECT treatment. The trial suits those who have successfully completed an initial course of ECT, are right-handed, and can give informed consent. As an unphased trial, it offers a unique opportunity to explore alternative maintenance therapies for depression.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Transcranial Magnetic Stimulation (TMS) is generally well-tolerated. Studies have found that TMS poses a lower risk to thinking and memory than Electroconvulsive Therapy (ECT). For instance, a large study found TMS effective for people with depression unresponsive to other treatments, similar to some medications but with fewer side effects. Another study showed that TMS helped prevent depression from returning in about 85% of patients over 24 weeks, with only mild side effects reported. Overall, TMS is considered a safe option for many people with depression, with most side effects being mild, such as headaches or scalp discomfort, which often improve over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for treating depression because it offers a non-invasive alternative to the current standard, Electroconvulsive Therapy (ECT). While ECT involves electrical stimulation of the brain and often requires anesthesia, TMS uses magnetic fields to stimulate nerve cells in specific brain regions, potentially reducing side effects and recovery time. Unlike ECT, which can sometimes impact memory and cognitive function, TMS is associated with fewer cognitive side effects. Additionally, TMS can be administered in an outpatient setting, offering more convenience and accessibility for patients.

What evidence suggests that this trial's treatments could be effective for depression?

This trial will compare Transcranial Magnetic Stimulation (TMS) with Electroconvulsive Therapy (ECT) for maintaining treatment of depression. Studies have shown that TMS can help treat depression that hasn't improved with other treatments. Some research indicates that TMS can significantly boost recovery and remission rates. Specifically, one study found that about 85% of patients who used TMS as their only treatment did not experience a return of depression symptoms after 24 weeks. However, results can vary, with different studies showing response rates between 30-60%. Overall, TMS is less likely to cause memory or thinking problems compared to ECT. ^{2 6 7 8 9}

Who Is on the Research Team?

Gopalkumar Rakesh, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with treatment-resistant major depressive disorder who have already undergone electroconvulsive therapy (ECT). Participants should prefer and be able to attend outpatient sessions, as they will choose between maintenance Transcranial Magnetic Stimulation (TMS) or continuing ECT.

Inclusion Criteria

Able to provide informed consent

Right-handed

My psychiatrist recommends maintenance TMS for me.

Exclusion Criteria

I have a history of seizures or a seizure disorder.

Related neurological disorder, or any other medical condition that would preclude TMS treatment determined by the treatment team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants choose between maintenance TMS or maintenance ECT. TMS involves 11 sessions over 6 months, while ECT is administered as per standard care.

6 months

11 visits (TMS), variable (ECT)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months.

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests if maintenance TMS can effectively maintain remission in patients with treatment-resistant depression compared to the standard maintenance ECT. It's a patient-preference trial, meaning participants choose their treatment without random assignment.

How Is the Trial Designed?

Group I: TMS Experimental Treatment 1 Intervention

Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. They will receive TMS in this arm of study for maintenance treatment of their depression and monitored with depressive scales.

Group II: ECT Active Control 1 Intervention

Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. If they elect to continue with maintenance ECT treatments which is the current standard of care, their depressive symptoms and cognitive functioning will be monitored accordingly.

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?

Austin Messner

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study comparing the effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) on major depression, both treatments showed similar outcomes at 3 and 6 months, with no significant differences in relapse rates or depression scores among the 41 patients involved.

Both treatment groups maintained low depression scores on the Hamilton Rating Scale and Global Assessment of Functioning, indicating that the benefits of rTMS are comparable to those of ECT over a 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three and six-month outcome following courses of either ECT or rTMS in a population of severely depressed individuals--preliminary report. Dannon, PN., Dolberg, OT., Schreiber, S., et al.[2019]

In a study involving 25 severely depressed patients, repetitive transcranial magnetic stimulation (rTMS) showed similar effectiveness to electroconvulsive therapy (ECT) in improving depression symptoms, with a mean percent improvement of 55% for rTMS compared to 64% for ECT.

Both treatments resulted in comparable outcomes on the Hamilton Depression Rating Scale and other secondary measures, indicating that rTMS can be a viable alternative to ECT for patients who may not tolerate or benefit from traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for major depression: preliminary results of a randomized trial. Janicak, PG., Dowd, SM., Martis, B., et al.[2021]

Repetitive Transcranial Magnetic Stimulation (rTMS) has a good overall safety profile for treating depression, with common side effects like headaches being minor and manageable.

While there is a low incidence of serious side effects such as seizures and hypomania, these are linked to specific risk factors, suggesting that proper screening can enhance patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Loo, CK., McFarquhar, TF., Mitchell, PB.[2021]

In a case series of 6 patients transitioning from maintenance ECT to TMS, all participants maintained or improved their depression status over 3 to 6 months, demonstrating TMS's effectiveness as a substitute treatment.

TMS was well tolerated, with minimal side effects reported, primarily headaches and scalp discomfort, making it a safer alternative for patients who experience adverse effects from ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation maintenance as a substitute for maintenance electroconvulsive therapy: a case series. Cristancho, MA., Helmer, A., Connolly, R., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) is generally a well-tolerated treatment for depression, with mild side effects like headaches being the most common, while severe adverse effects are rare.

Special precautions are necessary for certain groups, such as adolescents, pregnant women, and individuals with metal implants, but with proper assessment and monitoring, rTMS can be safely administered to many patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. Taylor, R., Galvez, V., Loo, C.[2019]

A patient with treatment-resistant depression (TRD) showed unexpected improvement after experiencing a seizure during repetitive transcranial magnetic stimulation (rTMS), suggesting a potential link between seizure activity and therapeutic effects in TRD.

While rTMS is generally safe, known adverse events include headaches and seizures; this case highlights an unusual outcome where a seizure may have contributed to the patient's improvement, warranting further investigation into the mechanisms of rTMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. Kim, JW., Bae, KY., Kim, SW., et al.[2020]

Citations

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

Efficacy of repetitive transcranial magnetic stimulation ... rTMS is significantly more effective than sham rTMS in TRD in response and remission outcomes and may be beneficial as an adjunctive treatment in patients with ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001128

Treatment expectations and clinical outcomes following ... For an estimated 20–30 % of individuals with MDD, standard treatments are ineffective, leading to a condition referred to as treatment-resistant depression (TRD) ...

4. nature.com nature.com/articles/s41398-025-03380-w

Predictive modeling of response to repetitive transcranial ... Findings presented in this study underscore the substantial variability in depression responses and remission, despite rTMS efficacy, and the ...

5. uclahealth.org uclahealth.org/news/release/study-finds-possible-early-predictor-successful-transcranial

Study finds possible early predictor of successful ... The effectiveness of rTMS has previously been observed as quite variable, with reported response rates ranging from 30-60%. Researchers at UCLA ...

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

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234753/

Utilization and outcomes of transcranial magnetic ... This analysis contributes to the growing body of evidence demonstrating that TMS is an effective intervention for treatment resistant MDD.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178121002833

Ten years' data of Transcranial Magnetic Stimulation (TMS) TMS responses of all patients were evaluated 26.1% as response, 29.2% as partial response, and 44.7% as inadequate response. •. It has been determined that MDD ...

9. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Results. If rTMS works for you, your depression symptoms may improve or go away completely. Symptom relief may take a few weeks of treatment.