rTMS Therapy for Depression
(SUNSET Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Psychotic disorders, Neurological conditions, Substance abuse, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. If you are on a regimen of psychotropic medication, you should not make any changes to it during the study.
What data supports the effectiveness of the treatment rTMS therapy for depression?
Repetitive transcranial magnetic stimulation (rTMS) has been shown to be effective in treating depression, with over 20 years of clinical trials supporting its use. It has been particularly beneficial for patients who have not responded well to traditional drug treatments, and studies suggest it is effective for both younger and older patients with depression.12345
Is rTMS therapy safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for treating depression, with common side effects including mild headaches and local pain. Rarely, it can cause seizures, but this is uncommon. Safety has been studied in both short-term and longer courses of treatment.678910
How is rTMS therapy different from other treatments for depression?
rTMS therapy is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is different from medications that work through chemical changes. It is a non-invasive treatment, meaning it doesn't require surgery or medication, and has been shown to be effective for people who haven't responded to other treatments.14111213
Eligibility Criteria
This trial is for adults aged 18-70 with Major Depressive Disorder currently experiencing a depressive episode without psychotic features. Participants must have moderate to severe depression, have tried 1-4 antidepressants without success, and be stable on current medications if any. They should be able to undergo non-invasive brain stimulation and commit to research visits for about 8 weeks.Inclusion Criteria
I am willing and able to have a treatment that involves stimulating my brain without surgery.
I've tried 1-4 antidepressants without success in this episode.
Has MADRS of > 19 at baseline, corresponding with moderate to severe depression
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Exclusion Criteria
Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents
Inability to comply with study daily visits
Inability to speak and/or read English
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Evaluation
Participants undergo baseline evaluation including resting-state fMRI, DTI, and EEG scans prior to TMS treatment
1 week
1 visit (in-person)
Treatment
Participants receive 30-40 daily sessions of rTMS to the dorsolateral prefrontal cortex, with mid- and post-treatment fMRI, DTI, and EEG scans
6-8 weeks
30-40 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including post-treatment evaluations
4 weeks
1-2 visits (in-person)
Treatment Details
Interventions
- rTMS therapy (Behavioural Intervention)
Trial OverviewThe study tests the effectiveness of rTMS therapy in treating Major Depressive Disorder by monitoring changes in brain activity through imaging techniques. It aims to identify reliable biomarkers that can predict treatment response and aid clinical diagnosis.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Morning rTMS treatmentExperimental Treatment1 Intervention
Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.
Group II: Afternoon rTMS treatmentExperimental Treatment1 Intervention
Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.
rTMS therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as rTMS therapy for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
🇪🇺 Approved in European Union as rTMS therapy for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
🇨🇦 Approved in Canada as rTMS therapy for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
🇦🇺 Approved in Australia as rTMS therapy for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. [2021]Repetitive transcranial magnetic stimulation (rTMS) is an increasingly used treatment for patients with depression. The use of rTMS in depression is supported by over 20 years of clinical trials. There has been a significant increase in knowledge around the use of rTMS in recent years.
Completeness of Descriptions of Repetitive Transcranial Magnetic Stimulation Intervention: A Systematic Review of Randomized Controlled Trials of rTMS in Depression. [2019]Repetitive transcranial magnetic stimulation (rTMS) is an innovative therapeutic option in major depressive disorder (MDD). A complete description of the procedure in reports of randomized controlled trials (RCTs) is a prerequisite for implementation of rTMS in clinical practice. The aim of this study was to evaluate the completeness of descriptions of the intervention in RCTs assessing rTMS in MDD.
Repetitive transcranial magnetic stimulation is effective following repeated courses in the treatment of major depressive disorder--a case report. [2014]Repetitive transcranial magnetic stimulation (rTMS) is a relatively new treatment modality for psychiatric patients. rTMS was demonstrated to be effective in the treatment of depression. However, longitudinal outcome studies have not yet been published. Relapse rates are higher in depressed patients and most of them do not respond to the same treatment with similar success. In this report we present a patient, who experienced relapse with the various conventional drug treatments, but responded well to rTMS at three different points in time.
[Therapeutic efficacy and safety of repetitive Transcranial Magnetic Stimulation in depressions of the elderly: a review]. [2010]During the past 15 years, therapeutic effects of repetitive Transcranial Magnetic Stimulation (rTMS) have been studied in psychiatric diseases, particularly in the treatment of depressive disorders. There are more and more data suggesting its efficacy in the treatment of depression in older patients. Thus, the authors found it useful to conduct an up-to-date review of studies that examined the efficacy and safety of rTMS to treat depressive disorders in the aged.
Rapid Symptom Improvement in Major Depressive Disorder Using Accelerated Repetitive Transcranial Magnetic Stimulation. [2022]Repetitive transcranial magnetic stimulation (rTMS) has contributed to increase in the remission rate for patients with major depressive disorder (MDD). However, current rTMS treatment is practically inconvenient because it requires daily treatment sessions for several weeks. Accelerated rTMS treatment is as efficient and safe for MDD patients as conventional rTMS.
Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. [2022]To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD).
Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]Repetitive transcranial magnetic stimulation (rTMS) is increasingly being utilised as a treatment option for depression, and with this comes a need for a practical review of safety issues intended for clinicians. This article provides an overview of the current literature regarding safety issues with rTMS for depression, and provides recommendations for clinical practice.
Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021]In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).
Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019]The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.
Treatment-Resistant Depression Entering Remission Following a Seizure during the Course of Repetitive Transcranial Magnetic Stimulation. [2020]Major depressive disorder is often resistant to antidepressant treatment. Repetitive transcranial magnetic stimulation (rTMS) has been used in treatment-resistant depression (TRD). Known adverse events of rTMS include transient headache, local pain, syncope, seizure induction, and hypomania induction. This report outlines a patient with TRD who unexpectedly improved following a seizure during the course of rTMS, which has never been reported.
Repetitive transcranial magnetic stimulation treatment for depressive disorders: current knowledge and future directions. [2020]After three decades of clinical research on repetitive transcranial magnetic stimulation (rTMS), major depressive disorder (MDD) has proven to be the primary field of application. MDD poses a major challenge for health systems worldwide, emphasizing the need for improving clinical efficacy of existing rTMS applications and promoting the development of novel evidence-based rTMS treatment approaches.
A practical guide to the use of repetitive transcranial magnetic stimulation in the treatment of depression. [2022]Repetitive transcranial magnetic stimulation (rTMS) is currently emerging as a new treatment for patients with mood disorders. Research into the use of rTMS for the treatment of patients with depression has been conducted now for a period of greater than 15 years and a considerable body of knowledge has accumulated informing its use.
A comparison of 15 minute vs 30 minute repetitive transcranial magnetic stimulation sessions for treatment resistant depression - are longer treatment sessions more effective? [2021]Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and effective treatment for treatment resistant depression (TRD). The number of patients able to be treated with rTMS is determined by the availability of the machine and staff. If treatment delivered in a shorter time were just as effective as longer treatments, then more patients could be treated with the same resources.