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Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation for Depression

N/A

Recruiting

Led By Paul Croarkin, DO, MS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age; The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age

Female or male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing a new type of transcranial magnetic stimulation to see if it reduces suicidal thoughts in adolescents with depression.

Who is the study for?

Adolescents aged 12-18 with Major Depressive Disorder and suicidal thoughts can join this trial. They must have a depressive episode lasting at least 4 weeks but under 3 years, and not show significant improvement before the trial starts. Participants need consent from a guardian, may be on antidepressants, and females must use birth control.Check my eligibility

What is being tested?

The study tests if theta burst stimulation (TBS), a new type of transcranial magnetic stimulation (TMS), helps reduce suicidal ideation in adolescents with depression over 10 days, monitoring outcomes for a year. It compares real TBS to sham (fake) treatment to see if there's an improvement.See study design

What are the potential side effects?

While specific side effects are not listed here, TMS can generally cause discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The severity varies among individuals.

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 according to DSM-5.

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I am either female or male.

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I am experiencing severe depression and have thoughts of harming myself.

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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 meet the safety requirements for TMS treatment.

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I may be taking antidepressants as advised by my doctor and agreed by my parents and me.

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I, or my guardian, can legally agree to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospitalizations

Suicidal Ideation

Secondary outcome measures

Cortical inhibition

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Sequential bilateral accelerated theta burst stimulationActive Control1 Intervention

Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Group II: Sham seqential billateral accelerated theta burst stimulationPlacebo Group1 Intervention

Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,783 Previous Clinical Trials

2,689,069 Total Patients Enrolled

665 Trials studying Depression

251,354 Patients Enrolled for Depression

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,004 Total Patients Enrolled

39 Trials studying Depression

3,475 Patients Enrolled for Depression

Paul Croarkin, DO, MSPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

MagVenture TMS Therapy System w/Theta Burst Stimulation (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04502758 — N/A

Depression Research Study Groups: Sham seqential billateral accelerated theta burst stimulation, Sequential bilateral accelerated theta burst stimulation

Depression Clinical Trial 2023: MagVenture TMS Therapy System w/Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04502758 — N/A

MagVenture TMS Therapy System w/Theta Burst Stimulation (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502758 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants involved in this experiment?

"Affirmative, the information hosted on clinicaltrials.gov implies that enrolment for this medical trial is ongoing. Initial posting date was April 4th 2022 and it was last amended on July 8th 2022. This investigation requires 80 participants from a single site to complete their study."

Answered by AI

Is enrollment for this research open to the public?

"This clinical trial needs 80 volunteers aged 12 to 18, currently struggling with suicidal ideation. In addition to this primary criterion, the patient must meet additional conditions such as inpatient or outpatient status and a certain level of depressive symptom severity demonstrated by CDRS-R total composite score. Furthermore, they should be female or male experiencing MDD for at least 4 weeks but less than 3 years; their symptoms should have not improved between screening and baseline visits by 25% or more; they need to eligible for transcranial magnetic stimulation (TMS) based on safety criteria104; finally, they must also fit DSM-5 diagnostic criteria122 with"

Answered by AI

Is the minimum age for participation in this experiment set at 18 years or younger?

"The criteria for enrolment in this trial necessitates that applicants are between 12 and 18 years old. There are currently 211 trials recruiting patients younger than 18, whereas 1005 are looking to recruit those over 65."

Answered by AI

Is recruitment still ongoing for this clinical experiment?

"According to clinicaltrials.gov, this particular medical trial is open for enrollment. The initial post was made on April 4th 2022 and the most recent edit occurred July 8th of that same year."

Answered by AI

Recent research and studies

Journal of Affective DisordersJournal

High-frequency Repetitive TMS for Suicidal Ideation in Adolescents with Depression

Croarkin, Paul E., Paul A. Nakonezny, Zhi-De Deng, Magdalena Romanowicz, Jennifer L. Vande Voort, Deniz Doruk Camsari, Kathryn M. Schak, John D. Port, and Charles P. Lewis. 2018. “High-frequency Repetitive TMS for Suicidal Ideation in Adolescents with Depression”. Journal of Affective Disorders. Elsevier BV. doi:10.1016/j.jad.2018.06.048.

Psychiatry ResearchJournal

Accelerated TMS for Depression: A Systematic Review and Meta-analysis

Sonmez, A. Irem, Deniz Doruk Camsari, Aiswarya L. Nandakumar, Jennifer L. Vande Voort, Simon Kung, Charles P. Lewis, and Paul E. Croarkin. 2019. “Accelerated TMS for Depression: A Systematic Review and Meta-analysis”. Psychiatry Research. Elsevier BV. doi:10.1016/j.psychres.2018.12.041.

NeuropsychopharmacologyJournal

Cortical Inhibitory Markers of Lifetime Suicidal Behavior in Depressed Adolescents

Lewis, Charles P., Paul A. Nakonezny, Caren J. Blacker, Jennifer L. Vande Voort, John D. Port, Gregory A. Worrell, Hang Joon Jo, Zafiris J. Daskalakis, and Paul E. Croarkin. 2018. “Cortical Inhibitory Markers of Lifetime Suicidal Behavior in Depressed Adolescents”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/s41386-018-0040-x.

Journal of Affective DisordersJournal