TMS for Depression

(MOOD Trial)

Overseen By Subha Subramanian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Subha Subramanian

Disqualifiers: Substance use disorder, Epilepsy, Neurological disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial magnetic stimulation (TMS) can reduce symptoms of depression. TMS uses magnetic fields to gently stimulate the orbitofrontal cortex (OFC), a brain area linked to mood and emotions. Participants will receive either active TMS or a sham (fake) version for comparison. Individuals with major depressive disorder, who are stable in their outpatient treatment and have not recently changed medications, might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future depression treatments.

What prior data suggests that transcranial magnetic stimulation is safe for treating depression?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated for treating depression. Studies have found that only about 10% of patients experience mild side effects, such as headaches or scalp discomfort. Importantly, over 10,000 treatment sessions have reported no serious issues like seizures or long-term effects. TMS is non-invasive, meaning it doesn't involve surgery, and is as safe as an MRI scan. This makes it a promising option for managing depressive symptoms without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, offering a non-invasive alternative to traditional antidepressants and psychotherapy. Most treatments for depression, like SSRIs or cognitive behavioral therapy, can take weeks to show results. However, TMS targets the brain directly and may produce faster antidepressant effects. Additionally, the study includes both active and sham stimulation, helping researchers differentiate the true impact of the magnetic pulses. Researchers are excited about TMS because it could provide a quicker and potentially more effective treatment option for individuals who don't respond well to current therapies.

What evidence suggests that transcranial magnetic stimulation might be an effective treatment for depression?

Research has shown that Transcranial Magnetic Stimulation (TMS) can significantly alleviate depression symptoms. In this trial, participants will receive either active OFC stimulation or sham OFC stimulation. A large study found that individuals with major depressive disorder (MDD) experienced significant improvements after TMS treatment. Specifically, 36% of patients achieved complete relief from their depression symptoms. Another study found that 54% of patients saw their symptoms improve by at least half. Overall, TMS is considered an effective option for many people with depression. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who can speak and understand English, have been diagnosed with major depressive disorder, are currently experiencing moderate to severe depression, and are stable in their outpatient treatment without recent medication changes or hospitalizations.

Inclusion Criteria

I am between 18 and 65 years old.

Must be able to read, speak and understand English

I am able to follow and complete all study procedures.

Exclusion Criteria

DSM-5 moderate to severe substance use disorder within the past three months, based on Structured Clinical Interview for DSM-5

Conditions that might result in increased risks of side effects or complications from rTMS or MRI: History of fainting spells of unknown or undetermined etiology that might constitute seizures, Diagnosis of epilepsy with the exception of a single seizure of benign etiology (e.g., febrile seizures) in the judgment of a board-certified neurologist, Current or past history of a neurological disorder, such as stroke, a progressive neurologic disease, or intracranial brain lesion(s); and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment, Any unstable medical condition, Any metal in the brain or skull (excluding dental fillings) unless cleared by the responsible covering MD, Any devices which could be affected by TMS or MRI such as a pacemaker, medication pump, nerve stimulator, cochlear implant, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD, Pregnancy; All female participants will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study. The pregnancy test will be administered by study staff trained to administer point of care pregnancy testing that complies with institutional laboratory policies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Phase

Participants undergo a triple-blind, randomized, sham-controlled phase comparing active versus sham OFC stimulation

10 days

2 visits (in-person)

Open-label Phase

All participants receive active OFC stimulation

10 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview

The study compares two groups: one receives active transcranial magnetic stimulation (TMS) targeting a brain area involved in mood regulation, while the other gets sham (placebo) TMS. The goal is to see if real TMS helps improve depression symptoms.

How Is the Trial Designed?

Group I: Active OFC stimulation Active Control 1 Intervention

Continuous intermittent theta burst stimulation (cTBS, a type of inhibitory TMS) to the right OFC.

Group II: Sham OFC stimulation Placebo Group 1 Intervention

Sham TMS treatment to the right OFC

Who Is Running the Clinical Trial?

Subha Subramanian

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Utilization and outcomes of transcranial magnetic stimulation ...

In this real-world study of a large sample of patients with MDD, TMS patients experienced statistically significant improvements in depression ...

2.

pmc.ncbi.nlm.nih.gov

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

Efficacy of repetitive transcranial magnetic stimulation (rTMS ...

Meta-analysis results: remission rates. Data on remission rates were available from 9 studies. The overall remission rate was 35.71% (120/336) ...

3.

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 ...

4.

brainstimjrnl.com

brainstimjrnl.com/article/S1935-861X(23)01926-5/fulltext

Dosing transcranial magnetic stimulation in major depressive ...

In a study of 7215 MDD patients, there were powerful associations between number of TMS sessions and effectiveness.

5.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2594387

Repetitive Transcranial Magnetic Stimulation for the Acute ...

Our data suggest that bilateral rTMS is probably more effective than LF-rTMS because their relative OR was only marginally not statistically significant and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6649915/

Use of Transcranial Magnetic Stimulation for Depression - PMC

This report reviews recent studies on the mechanism of action, patient eligibility, effectiveness, and safety of TMS in treating depression.

7.

brainstimjrnl.com

brainstimjrnl.com/article/S1935-861X(24)01263-4/fulltext

The safety and effectiveness of transcranial magnetic ...

Response rates were 53.85%, and 60%, remission rates were 42.31%, and 44.55% respectively. 9.97% of patients experienced adverse events related to TMS. The most ...

8.

mayoclinic.org

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

Transcranial magnetic stimulation

Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032722000507

Safety of transcranial magnetic stimulation in unipolar ...

Our systematic review and meta-analyses support the safety and tolerability of TMS techniques as an alternative monotherapy or as an add-on treatment for major ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4329899/

Efficacy and safety of deep transcranial magnetic stimulation ...

These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, ...