What side effects are associated with this type of intervention?

Common treatments for depression similar to Low-Frequency rTMS include various forms of transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). TMS side effects are generally mild and may include headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles, and lightheadedness. Serious side effects are rare but can include seizures. ECT, on the other hand, can cause short-term side effects such as confusion, memory loss, nausea, headache, jaw pain, or muscle ache. Long-term memory issues are a more serious concern with ECT.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for depression, including repetitive transcranial magnetic stimulation (rTMS). rTMS uses magnetic fields to stimulate nerve cells in the brain, which can alleviate symptoms of depression. Specifically, high-frequency rTMS targeting the left dorsolateral prefrontal cortex has been approved for treatment-resistant depression. Additionally, transcranial direct current stimulation (tDCS) and vagus nerve stimulation (VNS) have also been explored and approved for certain cases of depression. These treatments offer alternatives for patients who do not respond to traditional pharmacotherapy.

What other types of research exist?

Promising, novel alternatives to Low-Frequency rTMS for depression include: 1) Transcranial Magnetic Stimulation (TMS) with different protocols such as intermittent Theta Burst Stimulation (iTBS), which has shown efficacy in treatment-resistant depression. 2) Transcranial Direct Current Stimulation (tDCS), which uses a low electrical current to modulate neuronal activity. 3) Deep Brain Stimulation (DBS), which involves implanting electrodes in specific brain areas to regulate abnormal activity, though it is more invasive. 4) Vagus Nerve Stimulation (VNS), which stimulates the vagus nerve to influence mood regulation. 5) Electroconvulsive Therapy (ECT), which remains a highly effective treatment for severe depression, especially when other treatments have failed.

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Repetitive Transcranial Magnetic Stimulation

Brain Stimulation for Depression (LeRNIT Trial)

N/A

Recruiting

Led By Fidel Vila-Rodriguez, MD, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of brain stimulation therapies to help people with depression that hasn't improved with other treatments. These therapies use magnetic pulses to stimulate brain areas and improve mood.

Who is the study for?

This trial is for adults aged 18-65 with treatment-resistant depression, confirmed by specific criteria and interviews. Participants must have tried antidepressants without success or couldn't tolerate them, score ≥18 on a depression scale, not started new psychotropics recently, and can commit to the schedule. Exclusions include suicidal intent, psychotic/bipolar disorders history, recent substance use, pregnancy, metal head implants, significant medical issues or sensory impairments.

What is being tested?

The study compares two types of rTMS treatments for depression: low-frequency right-sided (LFR) stimulation versus intermittent theta burst stimulation (iTBS). It aims to determine if LFR is as effective as iTBS in patients who haven't responded well to standard antidepressant therapies.

What are the potential side effects?

rTMS side effects may include discomfort at the stimulation site, headache, lightheadedness or dizziness. Rarely it could cause seizures. Most side effects are mild and improve shortly after treatment sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Anxiety severity

Depression severity

Suicidal ideation

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Intermittent Theta Burst Stimulation (iTBS)Active Control2 Interventions

iTBS to the L-DLPFC

Group II: Low Frequency Right (LFR)Active Control2 Interventions

1Hz stimulation to the R-DLPFC

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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

Neuromodulation techniques, such as low-frequency repetitive transcranial magnetic stimulation (rTMS), work by using magnetic fields to stimulate nerve cells in specific areas of the brain associated with mood regulation, such as the dorsolateral prefrontal cortex. This stimulation can help to alleviate symptoms of depression by modulating neural activity and improving connectivity in brain circuits that are often dysregulated in depression. Understanding these mechanisms is crucial for patients as it highlights the potential of rTMS to provide relief when traditional treatments, like medications, are ineffective or not well-tolerated. Additionally, it underscores the importance of targeting specific brain regions to achieve therapeutic effects, offering a more personalized approach to treating depression.