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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow-up period (assessed montly)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been experiencing depression for more than 4 weeks but less than 3 years.
Select...
I am between 12 and 18 years old.
Select...
I have severe depression and thoughts of suicide.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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).
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Who is running the clinical trial?
Paul E. CroarkinLead Sponsor
3 Previous Clinical Trials
20 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,027 Total Patients Enrolled
665 Trials studying Depression
251,354 Patients Enrolled for Depression
Paul E Croarkin, DO, MSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken any experimental medication within the past 4 weeks.You have been diagnosed with a serious mental illness like schizophrenia, bipolar disorder, anorexia or bulimia, or have had problems with drug or alcohol abuse in the past year (except for caffeine and tobacco).I have a brain condition not caused by seizures and I'm not on seizure medication.I have had severe headaches or high brain pressure in the last year.I, or my guardian if I'm under 18, agree to participate in the trial.I meet the safety requirements for TMS treatment.I have had epilepsy or seizures that doctors couldn't explain.I have had electroconvulsive therapy or TMS treatment.I have a family history of epilepsy.You have metal implants in your head that could be affected by the magnetic field used in the study. Examples include cochlear implants, certain nerve stimulators, and metal objects like jewelry or hair accessories.I have a history of serious brain or nerve conditions.I have had severe head injuries or issues with high pressure in my brain.I do not have any unstable illnesses except for depression.I have been experiencing depression for more than 4 weeks but less than 3 years.I have been diagnosed with major depression.I am taking medication that could increase my risk of seizures.I have had a head injury that made me lose consciousness.I may be taking antidepressants as advised by my doctor and agreed by me and my parents.I am at risk for high pressure in my brain due to a tumor.I have had brain surgery before.I am either female or male.I am between 12 and 18 years old.I have severe depression and thoughts of suicide.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Comparison Group
- Group 2: Active Accelerated Sequential Bilateral Theta Burst Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to register for this medical experiment?
"This clinical trial is enrolling 80 minors (12-18 years old) exhibiting signs of suicidal ideation. Essential inclusion criteria include being an inpatient/outpatient, having the capacity to assent or consent if 18, meeting DSM-5 diagnosis criteria for MDD with associated score and severity thresholds on the CDRS-R & C-SSRS scales respectively, and no significant improvement between screening and baseline visits. Additionally, patients must meet basic safety requirements necessary for transcranial magnetic stimulation therapy."
Answered by AI
Is this experiment currently accepting participants?
"Unfortunately, the trial previously posted on clinicaltrials.gov is currently no longer accepting participants. The study was initially put forward on August 1st 2021 and last updated in April 29th 2021 but there are other 1364 trials needing enrollment right now."
Answered by AI
Are geriatric individuals among the participants of this experiment?
"This clinical trial stipulates that the minimum age of participants be 12, with a maximum aged capped at 18."
Answered by AI
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