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Transcranial Magnetic Stimulation

Accelerated TBS for Adolescent Depression

N/A

Waitlist Available

Led By Paul E Croarkin, DO, MS

Research Sponsored by Paul E. Croarkin

Eligibility Criteria Checklist

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

Must have

In a current episode of MDD with duration of at least 4 weeks but less than 3 years

12-18 years of age

Must not have

Patients suffering from vascular, traumatic, tumoral, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication

Patients with a history of increased intracranial pressure or history of severe headaches within the previous 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow-up period (assessed montly)

Summary

This trial is testing a new way to use transcranial magnetic stimulation to help with suicidal thoughts in teens with depression.

Who is the study for?

Adolescents aged 12-18 with Major Depressive Disorder and suicidal thoughts, who score a minimum on the C-SSRS severity scale. They must be able to consent or have guardian consent, not show significant improvement in depressive symptoms before starting, and can be on antidepressants if agreed upon. Exclusions include low IQ, drug use, epilepsy history, brain trauma/surgery, certain metal implants, pregnancy/nursing status.

What is being tested?

The trial is testing theta burst stimulation (TBS) using the MagVenture TMS Therapy System for reducing suicidal ideation in adolescents with depression over a period of 10 days and monitoring outcomes for one year. Participants will either receive real TBS treatment or a sham (fake) version as part of the study.

What are the potential side effects?

Possible side effects from TMS therapy may include discomfort at the site of stimulation on the head, headache, lightheadedness or dizziness. There's also a small risk of seizure during treatment but this is rare.

Eligibility Criteria

Inclusion Criteria

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

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I have been experiencing depression for more than 4 weeks but less than 3 years.

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I am between 12 and 18 years old.

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I have severe depression and thoughts of suicide.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain condition not caused by seizures and I'm not on seizure medication.

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I have had severe headaches or high brain pressure in the last year.

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I have had epilepsy or seizures that doctors couldn't explain.

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I have had electroconvulsive therapy or TMS treatment.

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I have a family history of epilepsy.

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I have a history of serious brain or nerve conditions.

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I have had severe head injuries or issues with high pressure in my brain.

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I do not have any unstable illnesses except for depression.

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I am taking medication that could increase my risk of seizures.

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I have had a head injury that made me lose consciousness.

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I am at risk for high pressure in my brain due to a tumor.

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I have had brain surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up period (assessed montly)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up period (assessed montly)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up period (assessed montly) 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 Number of Emergency Department Visits

Change in Number of Hospitalizations

Change in Suicidal Ideation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Accelerated Sequential Bilateral Theta Burst StimulationExperimental Treatment1 Intervention

Subjects will receive 11.5 minutes sessions of sequential bilateral TBS at 80% motor threshold, 3 times daily (1 hour apart) for 10 days in total (5 days per week).

Group II: Sham Comparison GroupPlacebo Group1 Intervention

Subjects will receive 3 daily bilateral sessions of sham TBS. Sessions in the comparison group are 11.5 minutes in duration, three times daily, for 10 days total (5 days per week).

0 / 15Eligibility criteria met