What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated, but common side effects include scalp discomfort at the stimulation site, headaches, and, rarely, seizures. Other common treatments for depression include antidepressant medications, which can cause side effects such as nausea, weight gain, sexual dysfunction, and insomnia. Electroconvulsive therapy (ECT) can lead to short-term memory loss, confusion, and physical side effects like muscle aches and headaches.

What prior FDA approvals exist?

Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that modulates neuronal activity in targeted brain regions to alleviate symptoms. Similar neuromodulation treatments include electroconvulsive therapy (ECT), which is also FDA-approved and used for treatment-resistant depression. ECT involves electrical stimulation to induce seizures and has been shown to be effective in severe cases. Additionally, single-pulse transcranial magnetic stimulation (TMS) has been approved for the acute treatment of migraine, demonstrating the broader applicability of TMS technology in neuromodulation therapies.

What other types of research exist?

Promising, novel alternatives to rTMS for depression patients include: 1) Deep Brain Stimulation (DBS) - an invasive procedure targeting specific brain regions, showing efficacy in treatment-refractory cases. 2) Transcranial Direct Current Stimulation (tDCS) - a non-invasive technique that uses a low electrical current to modulate brain activity, with emerging evidence supporting its use. 3) Noninvasive Vagus Nerve Stimulation (nVNS) - a non-invasive method that stimulates the vagus nerve, showing potential benefits for mood regulation. These alternatives offer different mechanisms of action and may be suitable for patients who do not respond to rTMS.

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Behavioural Intervention

Accelerated TMS for Depression and OCD

N/A

Recruiting

Led By Conor Liston, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-V criteria)

Failure to respond in the current episode to at least one antidepressant or other pharmacotherapy at an adequate dose and duration as measured by a modified antidepressant treatment history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new, faster treatment for people with depression and OCD. The goal is to see if this approach can quickly improve symptoms. The study also uses brain scans to find markers that predict who will benefit most from the treatment. This method has shown effectiveness in treating depression and cognitive impairment, and is being explored for its potential in treating OCD.

Who is the study for?

This trial is for adults with major depression or OCD who haven't improved after trying at least one medication. They must be stable on their current antidepressants, if any, and able to consent. People with psychotic symptoms, recent substance abuse, significant neurological disorders, imminent suicide risk, or other primary psychiatric diagnoses besides OCD or mild anxiety are excluded.

What is being tested?

The study tests an accelerated 5-day rTMS treatment using the MagVenture MagPro System aimed at rapidly improving depression and OCD symptoms. Participants will undergo fMRI scans to find biomarkers predicting TMS benefits. They'll receive intense daily rTMS sessions targeting specific brain areas over a week, possibly followed by another course if partially responsive.

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The intensity of side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression or OCD.

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My current depression treatment hasn't worked despite proper dosage and time.

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I am not on antidepressants or have been on a stable dose for 4+ weeks.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks0 visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression

Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD

Secondary study objectives

Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with OCD

Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with treatment resistant depression

Percent Change in 17-item Hamilton Depression Rating Scale (HAM-D) scores for participants with treatment resistant depression

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: OCD - DMPFC target to (for non-responders) LPFC targetExperimental Treatment1 Intervention

Participants with OCD will receive a 5-day course of rTMS delivered to the DMPFC.Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.

Group II: Depression - DMPFC target to (for non-responders) LPFC targetExperimental Treatment1 Intervention

Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the DMPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.

Group III: Depression - LPFC target to (for non-responders) DMPFC targetActive Control1 Intervention

Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.

Group IV: OCD - LPFC target to (for non-responders) DMPFC targetActive Control1 Intervention

Participants with OCD will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic fields to modulate neuronal activity in specific brain regions, particularly the prefrontal cortex, to alleviate symptoms of depression. This modulation can help restore normal brain function and improve mood. Other common treatments include selective serotonin reuptake inhibitors (SSRIs), which increase serotonin levels in the brain to enhance mood, and electroconvulsive therapy (ECT), which induces controlled seizures to reset brain activity. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and potential side effects.