Health TrialsbyHealthPanel

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

ConditionsSuicidal IdeationMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMayo Clinic

About this trial

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inpatients or outpatients

Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent

Female or male

12-18 years of age

Disqualifiers

Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).

Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123

Positive urine drug screen at baseline

Seizure history

Trial design

Design model

Parallel

Treatments tested in this trial

  • MagVenture TMS Therapy System w/Theta Burst Stimulation

    Device

    During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.

  • Sham MagVenture TMS Therapy System w/Theta Burst Stimulation

    Device

    During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Sequential bilateral accelerated theta burst stimulationActive comparator 1 intervention
Group B: Sham seqential billateral accelerated theta burst stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Suicidal Ideation

Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.

Time frame
up to 12 months
2

Hospitalizations

The total number of hospitalizations related to suicide idealization

Time frame
up to 12 months

Secondary outcomes

1

Cortical inhibition

As measured in Changes in test stimulus (TS) motor evoked potential (MEP) amplitude of are expressed as a percentage of the mean unconditioned MEP amplitude. For N100 response data collection, mean single pulse data will be collected for each electrode for the TMS-evoked potential. The N100 peak value is then extracted throughout electrodes from the negative in closest proximity to 100 ms.

Time frame
baseline, 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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