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

Trial Summary

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.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for depression?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is effective for treating major depression, with some studies indicating it can be as effective as electroconvulsive therapy (ECT). In one study, the remission rate for rTMS was similar to ECT, and while ECT showed slightly better results in some measures, rTMS still provided significant improvement in depressive symptoms. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

TMS, including its repetitive form (rTMS), is generally considered safe for humans when used within recommended guidelines. Common side effects are minor, like headaches, but there is a low risk of seizures and mood changes, which can be managed by screening for risk factors. ^{3 6 7 8 9}

How does the treatment rTMS differ from other treatments for depression?

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which is different from electroconvulsive therapy (ECT) that involves electrical stimulation. rTMS is generally well-tolerated and can be an alternative for patients who do not respond well to or cannot tolerate ECT. ^{1 2 10 11 12}

What is the purpose of this trial?

Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use. These barriers include procedure tolerability, cognitive side effects, financial burden, and unreliable social support to accompany patients for these treatments. On the other hand, a different modality of noninvasive neuromodulation called transcranial magnetic stimulation (TMS) can be performed in the outpatient setting and does not need anesthesia. The likelihood of cognitive adverse effects with TMS is much lower than with ECT. Our clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder. This will be a patient-preference clinical trial, with patients offered the choice to initiate maintenance TMS versus maintenance ECT after their index ECT sessions for treatment-resistant depression. There will be no randomization or placebo involved in this study.

Research Team

Gopalkumar Rakesh, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. [2021]

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

Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for major depression: preliminary results of a randomized trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Remission rate of transcranial magnetic stimulation compared with electroconvulsive therapy: a case-control study. [2019]

4. United States 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of unlimited numbers of rapid transcranial magnetic stimulation (rTMS) and ECT treatment sessions in major depressive episode. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]

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

Low-frequency repetitive transcranial magnetic stimulation inferior to electroconvulsive therapy in treating depression. [2012]

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

Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. [2020]

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

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. [2021]

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

Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for the treatment of major depressive disorder, a randomized controlled clinical trial. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Quality assessment and comparison of evidence for electroconvulsive therapy and repetitive transcranial magnetic stimulation for schizophrenia: a systematic meta-review. [2019]

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

Transcranial magnetic stimulation maintenance as a substitute for maintenance electroconvulsive therapy: a case series. [2021]