Transcranial Magnetic Stimulation for Adolescent Suicidal Thoughts

Overseen By Charles P Lewis, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antiepileptics, Benzodiazepines

Disqualifiers: Substance use disorder, Psychosis, Autism, 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: 3

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how brain signaling relates to impulsive actions during negative emotions in adolescents with depression and suicidal thoughts or behaviors. Researchers will use transcranial magnetic stimulation (TMS) to study brain communication and its link to impulsivity. The trial seeks participants aged 13-21 who have experienced depression and suicidal thoughts or behaviors. Participants will engage in interviews, questionnaires, and brain scans over the course of a year.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better understanding and treatment of depression and impulsivity in youth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using antiepileptic medications or chronic benzodiazepines. If you use benzodiazepines as needed, you can participate if you don't take them on the day of the TMS-EEG test.

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

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated in teenagers. TMS uses a magnet placed outside the head to affect brain activity and has been safely used to treat depression in adolescents. Studies suggest that with the right precautions, this treatment is safe and manageable for children and teens.

While some research is still ongoing, current findings on single- and paired-pulse TMS (a method to measure how brain cells communicate) are promising. Reports indicate only minor side effects, making it a relatively safe choice for young people. As with any treatment, discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial magnetic stimulation (TMS) for treating adolescent suicidal thoughts because it offers a non-invasive way to potentially improve mental health without medication. Unlike traditional treatments, like psychotherapy or antidepressants, TMS works by directly stimulating specific areas of the brain with magnetic pulses, which may help regulate mood and decrease suicidal thoughts. This technique could provide faster relief and be an alternative for those who haven't responded well to standard treatments. By measuring cortical inhibition through single-/paired-pulse TMS, researchers hope to gain insights into brain activity changes over time, paving the way for more personalized mental health care.

What evidence suggests that transcranial magnetic stimulation is effective for adolescent suicidal thoughts?

Research shows that transcranial magnetic stimulation (TMS) could be a promising treatment for depression in teenagers. Studies have found that TMS safely and effectively helps manage major depressive disorder (MDD) in young people. TMS uses magnetic fields to stimulate brain cells, lifting mood and reducing depression symptoms. In this trial, participants will undergo single or paired pulses of TMS to assess brain cell communication, offering insights into impulsive behaviors linked to negative emotions. Although researchers continue to study TMS, these early findings suggest it could benefit adolescents with depression and related issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Kathryn Cullen, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-18 with depression and suicidal thoughts or behaviors. They must be able to communicate in English, provide consent (or have a guardian do so if under 18), and not have a history of suicide attempts if only experiencing suicidal thoughts.

Inclusion Criteria

I have been diagnosed with depression.

I am under 18 and can sign an agreement, and my guardian can consent too.

My sex, gender, race, or ethnicity does not limit my participation.

Exclusion Criteria

Pregnancy or suspected pregnancy in participants capable of becoming pregnant (assessed with urine pregnancy test)

Current substance use meeting diagnostic criteria for a substance use disorder within the last month on the MINI or MINI-KID diagnostic interview (with the exceptions of caffeine and nicotine)

Historical diagnosis of autism spectrum disorder or intellectual disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial assessments including clinical interviews, questionnaires, computerized games, MRI, and TMS-EEG

1-2 weeks

1 visit (in-person)

6-Month Follow-up

Participants complete follow-up assessments including clinical interviews, questionnaires, and TMS-EEG

1-2 weeks

1 visit (in-person)

12-Month Follow-up

Participants complete final follow-up assessments including clinical interviews, questionnaires, and TMS-EEG

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Single-/paired-pulse transcranial magnetic stimulation

Trial Overview

The study tests how brain cell networks communicate during negative urgency using transcranial magnetic stimulation with EEG. It examines whether cortical inhibition relates to impulsivity in depressed teens, comparing those with suicidal behavior to those with thoughts only over time.

How Is the Trial Designed?

Group I: Longitudinal Assessments Experimental Treatment 1 Intervention

Participants in both groups (Dep/SI and Dep/SB) will undergo identical assessments at baseline, 6 months, and 12 months. Assessments will include clinical interviews and rating scales, questionnaires (including a self-report scale of negative urgency), and single-/paired-pulse transcranial magnetic stimulation (sp/ppTMS) measurement of cortical inhibition.

Single-/paired-pulse transcranial magnetic stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major depressive disorder
• Obsessive-compulsive disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

This study is the first randomized controlled trial investigating the efficacy of accelerated theta burst stimulation (aTBS) in treating suicidal ideation in adolescents with major depressive disorder (MDD), involving three daily sessions over 10 days.

The trial aims to address underlying neurotransmission deficits in the dorsolateral prefrontal cortex (DLPFC) and will measure biomarkers to understand the neurophysiological mechanisms of suicidal ideation, potentially leading to more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential bilateral accelerated theta burst stimulation in adolescents with suicidal ideation associated with major depressive disorder: Protocol for a randomized controlled trial. Yuruk, D., Ozger, C., Garzon, JF., et al.[2023]

In a study involving 19 adolescents with treatment-resistant depression, high-frequency repetitive TMS treatment significantly reduced suicidal ideation over 6 weeks, as measured by standardized scales.

However, when accounting for the severity of depression, the reduction in suicidal thoughts became non-significant, suggesting that improvements in suicidal ideation may be closely linked to overall depression symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency repetitive TMS for suicidal ideation in adolescents with depression. Croarkin, PE., Nakonezny, PA., Deng, ZD., et al.[2020]

A systematic review of 11 clinical trials involving 593 participants suggests that while repetitive Transcranial Magnetic Stimulation (TMS) effectively reduces depression, its specific impact on suicidal ideation remains uncertain.

A retrospective analysis of 43 veterans receiving TMS treatment showed significant decreases in suicidal thoughts, indicating that improvements in suicidality may occur independently of changes in depressive symptoms, highlighting the need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation to reduce suicidality - A review and naturalistic outcomes. Bozzay, ML., Primack, J., Barredo, J., et al.[2022]

In a study involving 120 active-duty military participants experiencing suicidal crisis, accelerated transcranial magnetic stimulation (TMS) showed a significant reduction in suicidal ideation compared to sham treatment, with a notable decline in scores measured by the Beck Scale for Suicidal Ideation (SSI-C).

Both active and sham TMS treatments led to rapid decreases in suicidal thoughts, but the active TMS group maintained significantly lower SSI-C scores for six months, indicating a lasting antisuicidal effect and a shift to much lower suicide risk levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation Promotes Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members. Hines, CE., Mooney, S., Watson, NL., et al.[2023]

In a study of 25 participants with PTSD and depression, 65% experienced a decrease in suicidal thoughts after 8 weeks of repetitive transcranial magnetic stimulation (TMS) targeting the left dorsolateral prefrontal cortex.

The reduction in suicidality was significantly correlated with changes in functional connectivity between the dorsal striatum and frontopolar cortex, suggesting that TMS may effectively alter brain connectivity related to suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Elements of Suicidality Reduction After Transcranial Magnetic Stimulation. Barredo, J., Berlow, Y., Swearingen, HR., et al.[2022]

This study aims to evaluate the effectiveness of combining repetitive transcranial magnetic stimulation (TMS) with brief cognitive behavioral therapy (BCBT) in reducing suicidal ideation and attempts among 130 veterans with recent suicidal behavior, marking the first clinical trial of its kind.

The research will assess treatment outcomes over a 12-week BCBT protocol with 30 sessions of TMS, potentially leading to improved interventions for veterans at risk of suicide if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans. Bozzay, ML., Primack, JM., Swearingen, HR., et al.[2022]

A high dose of left prefrontal repetitive transcranial magnetic stimulation (rTMS) delivered over three days to suicidal inpatients was found to be feasible and safe, with minimal side effects and no increase in suicidal thoughts during the treatment.

The study indicated a trend towards rapid improvement in suicidal thinking, particularly on the first day of treatment, suggesting that rTMS may have a quick anti-suicidal effect, although further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-site pilot randomized 3 day trial of high dose left prefrontal repetitive transcranial magnetic stimulation (rTMS) for suicidal inpatients. George, MS., Raman, R., Benedek, DM., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows promise in reducing suicidal ideation (SI) in patients with treatment-resistant depression, particularly in uncontrolled trials where a significant decrease in SI scores was observed (effect size g = 0.692).

In randomized controlled trials, while a decrease in SI scores was noted (g = 0.158), the effect was not statistically significant, indicating that more research is needed to fully understand the efficacy of rTMS for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Repetitive Transcranial Magnetic Stimulation on Suicidal Ideation in Treatment-Resistant Depression: A Meta-Analysis. Mehta, S., Konstantinou, G., Weissman, CR., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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Transcranial Magnetic Stimulation for Adolescent Depression

Transcranial magnetic stimulation (TMS) has increasingly been considered as an investigational treatment for adolescents with depression.

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sciencedirect.com

sciencedirect.com/science/article/pii/S016517812500215X

Safety and efficacy of Deep TMS for adolescent depression ...

Deep TMS is a safe and effective therapeutic option for adolescents and young adults suffering from MDD when delivered under routine outpatient treatment ...

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The Effectiveness of Transcranial Magnetic Stimulation in ...

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nature.com

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Neurodevelopmental considerations for transcranial ...

Applying TMS in single or paired pulses allows for measurement of corticomotor and cortico-cortical responses which can be captured using ...

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mdpi.com/2077-0383/14/18/6513

Exploring Applications of Transcranial Magnetic ...

TMS demonstrates potential as a safe and effective intervention for conditions such as depression, autism spectrum disorder, attention-deficit/hyperactivity ...