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Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04502758
Collaborator
National Institute of Mental Health (NIMH) (NIH)
80
Enrollment
1
Location
2
Arms
67.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MagVenture TMS Therapy System w/Theta Burst Stimulation
  • Device: Sham MagVenture TMS Therapy System w/Theta Burst Stimulation
 N/A

Detailed Description

The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). 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 theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program.

The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). 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 theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program.

The study will enroll outpatient and inpatient adolescents (aged 12-18 years) with Major Depressive Disorder (MDD) of at least moderate severity defined as a Children's Depression Rating Scale Revised (CDRS-R) Score of 40 or greater and suicidal ideation defined as a score of 3 or greater on item 13 (Suicidal Ideation) of the CDRS-R.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The use of the MagVenture Cool-B70 A/P coils facilitates blinding of the operator and subjects receiving aTBS or sham treatments. The study team members completing clinical rating scales will also not be allowed in the treatment suite during TBS treatment sessions and will be blinded to treatment assignment. A pre-post treatment expectancy and experience form will ask subjects and parents to make a guess regarding treatment arm (active or sham). Blinded study team members will also be asked to guess treatment assignments for each subject.
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sequential bilateral accelerated theta burst stimulation

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

Device: MagVenture TMS Therapy System w/Theta Burst Stimulation
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.
Other Names:
  • The MagVenture TMS Therapy System w/Theta Burst Stimulation

    		•
    Sham Comparator: Sham seqential billateral accelerated theta burst stimulation

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

    Device: Sham MagVenture TMS Therapy System w/Theta Burst Stimulation
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Suicidal Ideation [up to 12 months]

      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.

    2. Hospitalizations [up to 12 months]

      The total number of hospitalizations related to suicide idealization

    Secondary Outcome Measures

    1. Cortical inhibition [baseline, 10 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117

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

    • Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109

    • Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more

    • Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104

    • On a medically acceptable form of birth control if female

    • Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations.

    Exclusion Criteria:

    • 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

    • Any family history of epilepsy

    • History of any treatment with electroconvulsive therapy or TMS

    • Use of any investigational drug within 4 weeks of baseline

    • Prior brain surgery

    • Risk for increased intracranial pressure such as a brain tumor

    • Head trauma with loss of consciousness

    • Any true positive findings on the TMS safety screening form

    • Pregnancy or suspected pregnancy

    • Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).

    • Implanted medication pumps and cardiac pacemakers

    • Any unstable medical condition

    • Inability to adhere to the protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Paul Croarkin, DO, MS, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Paul E. Croarkin, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04701840
    Other Study ID Numbers:
    • 20-009630-1
    • R01MH124655-01
    • NCT04701840
    First Posted:
    Aug 6, 2020
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Paul E. Croarkin, Principal Investigator, Mayo Clinic
    Adolescent
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Suicidal Ideation

    Study Results

    No Results Posted as of Jul 12, 2022